bioihbjkbjnl/mcl2 huggingface dataset:
The Efficacy of Extra- Versus Intrafascial Injection for Supraclavicular Brachial Plexus Block
Condition: Upper Extremity Problem
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients will be randomized to one of two groups:

        1. Extrafascial injection group: Ultrasound-guided supraclavicular brachial plexus block
           with 2 injections of local anaesthetic, deposited at the exterior of the fascial sheath
           that surrounds the nerves

        2. Intrafascial injection group: Ultrasound-guided supraclavicular brachial plexus block
           with 2 injections of local anaesthetic, deposited at the interior of the fascial sheath
           that surrounds the nerves
    

Detailed description: 
      The study will be proposed to all patients undergoing formarm or hand surgery under axillary
      brachial plexus block. Patients will be randomized to one of two groups.

      The first group - extrafascial injection group - will receive an ultrasound-guided
      supraclavicular brachial plexus block whereby the local anesthetic will be deposited at the
      exterior of the fascial sheath that surrounds the nerves.

      The second group - intrafascial injection group - will receive an ultrasound-guided
      supraclavicular brachial plexus block whereby the local anesthetic will be deposited at the
      interior of the fascial sheath that surrounds the nerves.

      All patients will receive the same type and amount of local anesthetic: 30 ml of a mixture of
      ropivacaine 0.5 % + mepivacaine 1 %.

      The primary outcome is the rate of hemidiaphragmatic paresis 30 minutes after the block
      procedure, assessed with ultrasound. Secondary outcomes are: rate of hemidiaphragmatic
      paresis 2 hours after surgery, assessed with ultrasound, bedside spirometry before the
      supraclavicular block, 30 minutes after the block and 2 hours after surgery, rate of
      successful block 30 minutes after the block , duration of sensory and motor block, pain
      scores at rest and on movement at 24 h postoperatively, cumulative postoperative opioid
      consumption at 24 hours postoperatively and patient satisfaction with overall anesthetic
      management.

      These outcomes are further defined in the section below.
    

Intervention name(s): Extrafascial injection; Intrafascial injection
Intervention type(s): Procedure; Procedure
Intervention description(s): Extrafascial injection of local anaesthetic under ultrasound guidance; Intrafascial injection of local anaesthetic under ultrasound guidance
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: upper extremity surgery
tDCS and Motor Training and Motor Deficit After Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 3

Summary: 
      This study investigated the combined effects of anodal tDCS and intensive motor training (MT)
      vs. sham stimulation with MT (control intervention) on grip strength, motor performance and
      functional use of the affected arm in population of chronic stroke patients.
    

Detailed description: 
      A growing body of evidence are available regarding the effectiveness of anodal transcranial
      direct current stimulation (tDCS) in patients with chronic hand motor impairment as a stroke
      consequence.

      This study investigated the combined effects of anodal tDCS and intensive motor training (MT)
      vs. sham stimulation with MT (control intervention) on objective evaluation of fine and gross
      motor hand function using simulated activities of daily living (Jebsen-Taylor hand function
      test), grip strength, motor performance and functional use of the affected arm in this
      population of patients.

      Patients with chronic hand motor deficits after stroke (> 12 months) are randomly assigned to
      active stimulation or a control intervention arm in a double-blinded, sham-controlled,
      parallel design. Each group received intensive MT for 45 min/day, 5 days/week, for 2 weeks,
      which was preceded by 20 minutes of 2 milliampere of anodal tDCS over the ipsilesional M1 vs.
      sham tDCS.

      Outcome measures are tested at baseline (T0), and after the intervention Day 1 (T1), after
      stimulation protocol completion Day 10 (T2) and 30 days later (T3).
    

Intervention name(s): tDCS (Endomed 482; Enraf-Nonius B.V.)
Intervention type(s): Device
Intervention description(s): non-invasive brain stimulation with pair of electrodes with saline-soaked pads through which the direct current of intensity of 2 mA is delivered
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tDCS; motor recovery
A Safety and Efficacy Study of DRM02 in Subjects With Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether DRM02 is safe and effective in the
      treatment of plaque psoriasis when applied twice daily for 6 weeks.
    

Detailed description: 
      This is a double-blind, randomized, within-subject control, study enrolling 20 subjects with
      plaque psoriasis and designed to assess the safety, tolerability, and preliminary efficacy of
      DRM02.

      Safety will be assessed during the study, through adverse events, local skin responses,
      urinalysis, serum chemistry and hematology laboratory testing, physical examination and vital
      signs.

      Preliminary efficacy will be assessed through the Physician's Lesion Assessment (PLA) and the
      Severity of Psoriasis Area Severity Index (PASI) from only the two plaques identified at the
      baseline visit.
    

Intervention name(s): DRM02; Vehicle
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Intrauterine Adhesion Rate After Hysteroscopic Myomectomy and Application of HYALOBARRIER Gel
Condition: Myoma
MeSH terms: Myoma
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the intrauterine adhesion rate after the application
      of HYALOBARRIER Gel at the end of hysteroscopic myomectomy. Secondary endpoints were
      tolerance and side effect and subsequent fertility.
    

Detailed description: 
      Hysteroscopic myomectomy is the referent surgical treatment for submucous myoma. But
      intrauterine adhesion rate was evaluated about 7 to 15% after this procedure. The
      investigators hypothetically believe that application of HYALOBARRIER Gel at the end of the
      procedure, could be reduce the mean intrauterine rate to 50%. Thus, the investigators
      performed a multicenter (n = 20) prospective study non randomized in 220 patients with
      submucous myoma < 3 cm of diameter, evaluated by preoperative ultrasound. The investigators
      prefer this study design, because the principal reason is the number of enrolled patient were
      more 200 patients in each group with a double blind randomized study. Now, in all patients,
      after hysteroscopic myomectomy which performed with a same technique in each center (bipolar
      coagulation and physiologic serum), a diagnostic hysteroscopy was performed at 2 month to
      determinate the existence of intrauterine adhesion. Secondary end points were in this study
      the tolerance and side effects of HYALOBARRIER Gel and the subsequent fertility at 2 years.
    

Intervention name(s): HYALOBARRIER Gel
Intervention type(s): Device
Intervention description(s): For each patient, the HYALOBARRIER Gel was introduced into the uterine cavity with the canula after hysteroscopic myomectomy procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Uterine synechiae; HyalobarrierR Gel Endo; Operative hysteroscopy; submucous myoma
Study of ZSP1273 in Patients With Acute Uncomplicated Influenza A
Condition: Influenza A
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the antiviral effect, as measured by the time to
      alleviation of influenza symptoms and viral titer in nasopharyngeal secretions in adults with
      acute uncomplicated influenza A following administration of ZSP1273.
    


Intervention name(s): ZSP1273 200 mg; Placebo; ZSP1273-400 mg; Placebo; ZSP1273-600 mg; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 1 X 200-mg tablet taken orally; 2 tablets taken orally; 2 X 200-mg tablet taken orally; 1 tablet taken orally; 3 X 200-mg tablet taken orally; 3 tablets taken orally; Subjects will receive matching placebo of ZSP1273
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Randomized, Open-label, Multiple-dose, Two-sequence, Two-period Crossover Study to Investigate The Pharmacokinetics Between a GL2907 and Oxycontin CR Tab. 10mg in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical trial is to compare the pharmacokinetic characteristics of
      GL2907 XL 20mg tablet and Oxycontin CR 10mg tablet.
    

Detailed description: 
      GL2907 XL 20mg tablet is controlled released formulation which is made by GL Pharm Tech.
    

Intervention name(s): GL2907; Oxycontine CR 10mg
Intervention type(s): Drug; Drug
Intervention description(s): once a day; twice a day
Other intervention name(s): Oxycodone HCl 20mg; Oxycodone HCl 10mg
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Oxycodone, controlled release formulation
Effect of Virtual Reality-Based Visual Training for Myopia Control in Children
Condition: Myopia; Myopia, Progressive
MeSH terms: Myopia; Myopia, Degenerative
Study type: Interventional

Summary: 
      To assess the efficacy and safety of virtual reality-based visual training (VRVT) in myopia
      control among children.
    


Intervention name(s): Virtual reality visual training
Intervention type(s): Device
Intervention description(s): Children in intervention group were administered at home under the supervision of parents for 20 minutes per session every day with virtual reality visual training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Influence of Molecular Abnormalities on Response of VAH vs. VEN+HMA in RR-AML
Condition: Relapsed Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia; Gene Abnormality; Cytogenetic Abnormality
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Congenital Abnormalities; Chromosome Disorders; Chromosome Aberrations
Study type: Observational

Summary: 
      The aim of this study is to reveal the influence of gene mutations on the treatment response
      of the regimen of HHT combined with Venetoclax plus AZA versus venetoclax plus HMA in the
      salvage therapy of RR-AML.
    

Detailed description: 
      Venetoclax-based regimens have heen used in the salvage therapy of relapsed/resfractory (RR)
      acute myeloid leukemia (AML). More and more studies have shown that molecular abnormalities
      and venetoclax combined regimens significantly impact the response of venetoclax-based
      therapy. Our exploratory study revealed that venetoclax plus azacytidine combined with
      homoharringtonine (VAH) had remarkably higher response than venetoclax plus hypomethylating
      agents (HMA) in RR-AML. Yet the influence of molecular abnormalities on the response of VAH
      regimen remains unknown.
    

Intervention name(s): VAH regimen; VEN+HMA regimen
Intervention type(s): Drug; Drug
Intervention description(s): VEN was prescribed as 100mg day 1, 200mg day 2, 400mg day 3-14; AZA was used at the dose of 75 mg/m2, day 1-7; HHT was given at a dose of 1mg/m2, day 1-7. The dose of VEN was reduced to 100mg/d if co-administered with posaconazole or voriconazole.; VEN was prescribed as 100mg day 1, 200mg day 2, 400mg day 3-28; AZA was used at the dose of 75 mg/m2, day 1-7 or DEC 20mg/m2 day 1-5. The dose of VEN was reduced to 100mg/d if co-administered with posaconazole or voriconazole.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Cases included in this study were from 3 previous studies of our study group, including 1
        exploratory and 2 prospective studies.
      
Biospecimen description: 
      Bone marrow and/or peripheral blood were taken from participants upon enrollment for
      diagnosis and detection of gene mutations and co-mutations via PCR, direct sequencing and /or
      next generation sequencing.
    
Keywords: Acute myeloid leukemia; Relapsed/refractory; Gene mutation; Venetoclax; Homoharringtonine
Citrate Versus Heparin in Continuous Renal Replacement Therapy :
Condition: Acute Kidney Injury; Citrate; Cytokines; Hemodynamic Responses
MeSH terms: Acute Kidney Injury
Study type: Interventional

Summary: 
      This study is a prospective, multicenter, open-label randomized trial comparing regional
      citrate anticoagulation (RCA) with heparin-free protocol. The function mode was continuous
      venovenous hemodiafiltration (CVVHDF) in post-dilution mode. The investigators measured
      hemodynamic changes at certain time points after starting CRRT (0, 6, 12, 24, 48, 72
      hr).Levels of inflammatory cytokine (IL-1β, IL-6, IL-8, IL-10 and TNF-ɑ) were measured at day
      1 and day 3
    

Detailed description: 
      Twenty patients were randomized into heparin group and 11 patients were in citrate group. The
      cardiac performance were not significantly different between 2 groups at every time point.
      The inflammatory cytokines declined similarly in both treatment arms. The maximum filter
      survivial time was longer in a RCA group but not reach statistically significant (44.64±26.56
      hr vs p=0.693 in citrate and heparin free group respectively).There was no serious side
      effects dung both treatment arm even in the group of liver dysfunction patients.
    

Intervention name(s): Regional citrate anticoagulation
Intervention type(s): Procedure
Intervention description(s): The investigators collected patient's plasma at study start (day 0) and at day 3, 5, 7, 14, 28) .Samples were used to measure inflammatory markers (Il 6, IL 8, IL 10 and TNFα) .
. Markers of dialysis efficiency (BUN, creatinine) and other parameters related to AKI (acid base status, calcium, phosphorus, hemoglobin). The recorded variables also included adverse events, dialysis clotting, hemodynamic status, duration of mechanical ventilation, inotropic support. The hemodynamic parameters were monitored by EV 1000 clinical platform .The investigators measured cardiac performance data, which includes cardiac output (CO), cardiac index (CI), stroke volume (SV), and stroke volume indexes (SVI). Moreover, it also provides information about systemic vascular resistance (SVR). Thus, patient hemodynamic parameters as mentioned above were measured at the following 6 time-point: after the initiation of CRRT (T1), every 6 hours later for 24 hours (T2, T3, T4, T5), and at hour-72 (T6).
Other intervention name(s): Heparin-free
Intervention MeSH terms: Heparin
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: This study is a prospective,multicenter, open-label randomized trial
Masking: Single (Care Provider)
Primary purpose: Treatment
Comparison of an Interscalene Nerve Block With or Without Stellate Ganglion Block for Shoulder Surgery
Condition: Anesthesia, Regional
MeSH terms: Ganglion Cysts
Study type: Interventional
Phase: Phase 4

Summary: 
      This study describes the difference of analgesic effect of levobupivacaine 0.5% administered
      through an interscalene nerve block with or without a stellate ganglion block. The length of
      the analgesic effect is our primary outcome parameter. Half of the recruited patients will
      receive a stellate ganglion block and half of the patients won't.
    


Intervention name(s): Levobupivacaine; NaCl 0.9%
Intervention type(s): Drug; Drug
Intervention description(s): Inject 3ml of levobupavacaine into the stellate ganglion area; Inject 3ml of NaCl 0.9% into the stellate ganglion area
Intervention MeSH terms: Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Investigate the Safety and Immunogenicity of Different Formulations of GSK Biologicals' Meningococcal ACWY Conjugate Vaccine (GSK3536820A and Menveo) Administered to Healthy Adults 18 to 40 Years of Age
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      MenACWY (Menveo) is a GSK vaccine intended for protection against disease caused by
      meningococcal bacteria groups A, C, W and Y in infants, children and adults, licensed in more
      than 60 countries.

      The purpose of this study is to compare the immunogenicity of the currently licensed MenACWY
      vaccine with the investigational MenACWY liquid vaccine.
    


Intervention name(s): MenACWY liquid vaccine with approximately 30% MenA FS (GSK3536820A); Licensed GSK MenACWY vaccine (Menveo)
Intervention type(s): Biological; Biological
Intervention description(s): Single dose administered at Day 1, by intramuscular injection in the deltoid of the non-dominant arm; Single dose administered at Day 1, by intramuscular injection in the deltoid of the non-dominant arm
Other intervention name(s): GSK3536820A
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Meningitis; Liquid formulation; Meningococcal disease
Vaginal Progesterone Supplementation in the Management of Preterm Labor
Condition: Preterm Labor
MeSH terms: Premature Birth; Obstetric Labor, Premature
Study type: Interventional

Summary: 
      This study evaluates the addition of vaginal progesterone in the management of preterm labor.
      Half of participants will receive vaginal progesterone, tocolysis and corticosteroid, while
      the other half will receive only tocolysis and corticosteroid.
    


Intervention name(s): progesterone; Tocolytics; Steroids
Intervention type(s): Drug; Drug; Drug
Intervention description(s): vaginal utrogestan; tocolysis for 48 hours; antenatal corticosteroids for 48 hours
Other intervention name(s): utrogestan
Intervention MeSH terms: Tocolytic Agents; Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Clinical Comparison of Universal Adhesives in Terms of Different Application Modes on the Restoration of NCCLs
Condition: Tooth Wear
MeSH terms: Tooth Wear
Study type: Interventional

Summary: 
      The aim of this randomized, controlled, prospective clinical trial is to evaluate the
      performances of two different universal adhesives and an etch&rinse adhesive in restoration
      of non-caries cervical lesions. Twenty patients will receive restorations. Lesions will be
      divided into 7 groups according to adhesive systems and application modes: GSE: Gluma
      Universal- self etch, GSL: Gluma Universal-selective etching, GER: Gluma
      Universal-etch&rinse, ASE: All Bond Universal- self etch, ASL: All Bond Universal- selective
      etching, AER: All Bond Universal- etch&rinse, SB (Control): Single Bond2+etch&rinse.
      Restorations (nano-hybrid composite) will be scored with regard to retention, marginal
      discoloration, marginal adaptation, recurrent caries and post operative sensitivity using
      modified USPHS criteria after 48 months. Two examiners who is not involved in the placement
      of restorations will conduct the evaluations. Descriptive statistics will be performed using
      Chi-square tests.
    


Intervention name(s): Gluma Universal; All Bond Universal; Single Bond2
Intervention type(s): Device; Device; Drug
Intervention description(s): Adhesive systems; Adhesive systems; Adhesive systems
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Interactive Informed Consent and Decision Conflict
Condition: Upper Extremity Problem
Study type: Interventional

Summary: 
      Informed consent for surgery can address the legal aspects while also being simple,
      informative, and empathic. It can help people confirm that the potential harms are acceptable
      in light of the potential benefits. Standard consent forms just document this process, while
      a computer-based, interactive consent process can also standardize and potentially enhance
      it.
    

Detailed description: 
      It's not clear that the current informed consent process adequately addresses common
      misconceptions and adequately confirms patient understanding of potential harms and potential
      benefits. Thoughtful patient consideration of potential benefits and potential harms of
      surgery might be facilitated by a step-by-step, iterative, interactive electronic consent
      process designed to help patients: 1) become aware of their values, 2) understand the actual
      and potential harms of surgery, 3) understand the potential benefits of surgery, and 4) guide
      people away from common misconceptions and towards decisions based on their values.
    

Intervention name(s): Interactive consent; Standard consent
Intervention type(s): Other; Other
Intervention description(s): They were randomized to complete an interactive consent.; They were randomized to complete a standard written consent.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science