bioihbjkbjnl/mcl2 huggingface dataset:
IV Dexamethasone for Prolongation of Peripheral Nerve Block
Condition: Anesthesia, Conduction
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a volunteer study examining the effect of different doses of IV dexamethasone on
      prolongation of median nerve block in the forearm.
    

Detailed description: 
      18 healthy volunteers aged 18-50 will be recruited (6 patients in each dosing group). Each
      volunteer will receive two forearm median nerve blocks separated by a two week washout
      period. One block will be conducted alongside an infusion of normal saline (control). The
      other block will be conducted alongside a randomised dose of IV dexamethasone (2, 4 or 8mg).
      The order of these interventions will be random. Blocks will be assessed quantitatively with
      cold and sharp sensation, electrical stimulation, quantitative sensory testing (thermal
      tolerance) and grip strength dynamometry. Measures or sensory and motor block including
      onset, intensity and duration will be compared between dosing groups.
    

Intervention name(s): IV dexamethasone
Intervention type(s): Drug
Intervention description(s): An infusion of IV dexamethasone
Other intervention name(s): Dexamethasone sodium phosphate injection USP
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Dexamethasone 21-phosphate; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Regional anesthesia; Adjuvant; Dexamethasone
Effect of Equal Ratio Ventilation on Blood Loss During Posterior Lumbar Interbody Fusion Surgery
Condition: Blood Loss, Surgical
MeSH terms: Hemorrhage; Blood Loss, Surgical
Study type: Interventional

Summary: 
      Ventilator mode change was associated with decrease in blood loss during posterior lumbar
      interbody fusion (PLIF) due to decrease in the peak inspiratory pressure (PIP). The purpose
      of this study was to determine the effect of equal ratio ventilation (ERV), which sets the
      I:E ratio of the ventilator to 1:1 during volume controlled ventilaiton, on surgical blood
      loss during PLIF. Investigators hypothesized that ERV would decrease surgical blood loss due
      to decrease in the PIP.
    

Detailed description: 
      After anesthesia, patients will receive ventilator settings according to theri group. The CVP
      will be measured before and after the prone position to ensure the proper positioning. Airway
      pressures including peak inspiratory pressure, mean/plateau airway pressure, arterial blood
      gas analysis data, hct, lactate, body temperature, mean arterial pressure, cardiac index.
      Recodings will be done 5min afte the induction, 5 min after the prone positioning, sikin
      suture, and 5min after supine position. Amount of bleeding, coagulation profile and Hct will
      be recorded 72 hrs after the surgery.
    

Intervention name(s): Equal ratio ventilation(ERV); I:E Ratio "1:2
Intervention type(s): Other; Other
Intervention description(s): Set the inspiratory to expiratory ratio 1:1 during mechanical ventilation; Set the inspiratory to expiratory ratio 1:2 during mechanical ventilation
Other intervention name(s): I:E ratio 1:1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Equal ratio ventilation(ERV); Peak inspiratory pressure(PIP); Blood loss; Posterior lumbar interbody fusion(PLIF); Prone position
Bobath Approach On Hemiplegic Shoulder Pain
Condition: Hemiplegic Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional

Summary: 
      In this study, it is investigated that whether Bobath approach is superior to conventional
      physiotherapy in terms of improving hemiplegic shoulder pain, spasticity and upper extremity
      functionality in stroke patients.
    

Detailed description: 
      Objective: This study aims to determine the effect of Bobath approach on hemiplegic shoulder
      pain, spasticity and upper extremity functionality in stroke patients.

      Patients and Methods: For this prospective, randomized, controlled and single-blind trial, 30
      stroke patients aged 40-65 years with hemiplegic shoulder pain were included. Patients were
      divided into two groups and randomized into these groups. Only conventional physiotherapy was
      applied to the control group, whereas both conventional physiotherapy and Bobath exercises
      were also applied to the experimental group. Visual analog scale (horizontal) for shoulder
      pain, modified Ashworth scale for spasticity and Fugl-Meyer assessment of the upper extremity
      for functionality were used for both pre-test and post-test.
    

Intervention name(s): Bobath treatment approach; Conventional physiotherapy
Intervention type(s): Procedure; Procedure
Intervention description(s): scapulothoracic mobilization exercise, reaching in different directions in the supine position and upper extremity weight transfer exercise.; range of motion, stretching, strengthening exercises, electrotherapy, thermotherapy, balance and mobility exercises and exercises for daily living activities.
Other intervention name(s): Neurodevelopmental treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A PROSPECTIVE, RANDOMIZED, CONTROLLED AND SINGLE-BLIND TRIAL
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Hemiplegia; hemiplegic shoulder pain; neurodevelopmental treatment; spasticity; stroke
Comparison of Medical and Surgical Treatment of Uncomplicated Acute Appendicitis in Children
Condition: Appendicitis
MeSH terms: Appendicitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Several prior studies have demonstrated that medical management of acute appendicitis in
      adults is a safe first-line therapy option. This study aims to determine whether
      non-operative management of uncomplicated acute appendicitis with antibiotics is non-inferior
      to operative management in a pediatric population. This study will be a randomized controlled
      trial comparing non-operative management with antibiotics to surgical management of
      uncomplicated acute appendicitis. The hypothesis is that antibiotics are not worse than
      surgery for the treatment of uncomplicated appendicitis in children.
    


Intervention name(s): Piperacillin/Tazobactam; Surgical Treatment
Intervention type(s): Drug; Procedure
Intervention description(s): 24 hours of IV antibiotic administration; Appendectomy
Other intervention name(s): Appendectomy
Intervention MeSH terms: Tazobactam; Piperacillin; Piperacillin, Tazobactam Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Estimate How Common it is to Have Genetic Variants Associated With NAFLD
Condition: Healthy
Study type: Observational

Summary: 
      The purpose of this study is to estimate the prevalence of genetic variants associated with
      liver disease in participants who are known, or are likely to have NAFLD.
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No investigational medicinal product will be administered as a part of this study.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants, who are known to have, or are likely to have, NAFLD.
Role of Exenatide in NASH-a Pilot Study
Condition: Nonalcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      We hypothesize that exenatide (Byetta), a GLP-1 agonist administered subcutaneously for 24-28
      weeks improves liver histology in diabetic patients with biopsy-proven NASH.
    

Detailed description: 
      Eight adult patients with known type 2 DM(Diabetic) and biopsy-proven NAFLD were treated with
      5-10 mcg subcutaneous exenatide for 28 weeks. Liver histology was assessed using the NAFLD
      Activity Score (NAS) prior to therapy and after 28 weeks of therapy. We used the following
      criteria to define our primary outcome: (i) no worsening of fibrosis score, (ii) improved
      score by at least one point in hepatocyte ballooning, (iii) either (a) improvement in NAS by
      2 or more points spread across at least two of the three NAS components, or (b)
      post-treatment NAS equal or greater than 3.
    

Intervention name(s): Exenatide
Intervention type(s): Drug
Intervention description(s): 5 mcg twice a day titrated to 10 mcg twice a day
Other intervention name(s): Byetta
Intervention MeSH terms: Exenatide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Non-alcoholic steatohepatitis; NASH
Randomized Study of Succimer (Dimercaptosuccinic Acid) on Growth of Lead-Poisoned Children
Condition: Lead Poisoning
MeSH terms: Poisoning; Lead Poisoning
Study type: Interventional

Summary: 
      OBJECTIVES:

      Compare growth of lead-poisoned children receiving succimer (dimercaptosuccinic acid; DMSA)
      plus standard treatment to those receiving standard treatment only.
    

Detailed description: 
      PROTOCOL OUTLINE: This is randomized study. Patients are randomized to receive succimer in
      addition to standard treatment (arm I) or standard treatment only (arm II).

      Succimer is administered orally 3 times a day for 7 days, then twice daily for 19 days.
      Patients may receive up to 3 courses.

      Standard treatment consists of a medical history and physical examination, environmental
      assessment with modification to reduce lead exposure, dietary modifications to decrease lead
      absorption, the use of a daily multivitamin and mineral supplement with iron, developmental
      screening and intervention, and frequent follow up of lead levels.

      If blood lead level rises above 45 mcg/dL, patient receives succimer regardless of treatment
      arm originally assigned.

      Patients are followed every 3-4 weeks for 2 months, then every 3 months for 6 months, and
      then every 6 months thereafter.
    

Intervention name(s): succimer
Intervention type(s): Drug
Intervention MeSH terms: Succimer
Allocation: Randomized
Primary purpose: Treatment
Keywords: environmental/toxic disorders; lead poisoning; rare disease
Placebo-Controlled Trial of Safety and Efficacy of Thalidomide in Patients With Infections Due to Mycobacterium and/or HIV
Condition: Mycobacterium Avium-Intracellulare Infection; HIV Infections; Tuberculosis, Mycobacterium Infection
MeSH terms: Infections; Communicable Diseases; Tuberculosis; Mycobacterium Infections; Mycobacterium avium-intracellulare Infection
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate, in patients with tubercular or nontubercular mycobacterium infections with or
      without HIV infection, the safety of thalidomide use as judged by symptoms, physical exam,
      and studies of microbiologic, immunologic, hematologic, renal, and hepatic status. To
      demonstrate efficacy of the drug as judged by status of fever, nutrition, tuberculosis
      lesions, and immune responses.
    

Detailed description: 
      Patients are randomized to receive thalidomide or placebo orally at 9 PM the night before
      beginning anti-tuberculosis chemotherapy and continuing nightly for 7 nights. Patients are
      followed for 28 days. Patients are stratified according to HIV status and stage of HIV
      infection.
    

Intervention name(s): Thalidomide
Intervention type(s): Drug
Intervention MeSH terms: Thalidomide
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: Mycobacterium tuberculosis; Mycobacterium Infections; AIDS-Related Opportunistic Infections; Mycobacterium avium-intracellulare Infection; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Mycobacterium Infections, Atypical; Thalidomide
Bevacizumab After Chemoradiotherapy For Locally Advanced Lung Adenocarcinoma
Condition: Lung Adenocarcinoma
MeSH terms: Adenocarcinoma; Adenocarcinoma of Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      This prospective phase II study is to determine the efficacy and safety of bevacizumab
      maintenance therapy after concurrent chemoradiotherapy in locally advanced lung
      adenocarcinoma
    

Detailed description: 
      This prospective phase II study is to determine the efficacy and safety of bevacizumab
      maintenance therapy after concurrent chemoradiotherapy in locally advanced lung
      adenocarcinoma.

      All patients received 4 cycles of weekly docetaxel (25mg/㎡) and nedaplatin (25mg/㎡)(DP), each
      of 1 day's duration, combined with split-course thoracic radiotherapy, with one-month
      break.Bevacizumab maintenance therapy starts 1-2 months later after the chemotherapy.The
      recommended dose for intravenous infusion is 15mg/kg body weight, and the drug is given every
      3 weeks for up to 1 year. Toxicities will be graded according to National Cancer Institute
      Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0.
    

Intervention name(s): Bevacizumab; chest radiation; concurrent chemotherapy
Intervention type(s): Drug; Radiation; Drug
Intervention description(s): Patients are treated with Bevacizumab 1-2 months after the chemoradiotherapy.The recommended dose for intravenous infusion is 15mg/kg body weight, which is given every 3 weeks for up to 1 year.; split-course chest radiation; weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡) concurrent with chest radiation
Intervention MeSH terms: Bevacizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bevacizumab; Split-course Chemoradiotherapy
AllogeneiC Human Mesenchymal Stem Cells (hMSC) in Patients With Aging FRAilTy Via IntravenoUS Delivery
Condition: Frailty
MeSH terms: Frailty
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to look at the safety of treatment with stem cells in patients
      with Frailty.
    


Intervention name(s): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs); Placebo; Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion; Placebo administered by peripheral intravenous infusion.; Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion.
Intervention MeSH terms: Penicillins; Streptomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Aging Frailty; Frailty; Cardiovascular; Stem Cells
Efficacy and Safety of Prophylactic Use of an Antibiotic for Medical Thoracoscopy
Condition: Pleural Effusion; Pleurisy; Empyema
MeSH terms: Empyema; Pleurisy; Pleural Effusion
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective study to assess the efficacy and safety of a single dose of cefazolin
      2g IV for the prophylaxis of surgical site and pleural space infections in patients
      undergoing medical thoracoscopy.
    

Detailed description: 
      This is a prospective randomized study to assess the efficacy and safety of a single dose of
      cefazolin 2g IV for the prophylaxis of surgical site and pleural space infections during
      medical thoracoscopy.

      Consecutive patients who are planned to undergo a medical thoracoscopy (rigid or semirigid)
      will be enrolled in the study if they satisfy the inclusion and exclusion criteria. One
      hundred patients will be randomized in 1:1 ratio to receive either of the following: (a) A
      single dose of intravenous cefazolin 2 gms dissolved in 100 mL of normal saline administered
      over 10 minutes, between 15 and 30 minutes before the incision, OR (b) 100 mL normal saline
      administered intravenously over a period of 10 minutes between 15 and 30 minutes before the
      incision. Thoracoscopy will be performed in the bronchoscopy suite on a spontaneously
      breathing subject (fasting for 8 h) under conscious sedation (using midazolam, pentazocine,
      and tramadol) observing complete aseptic precautions.
    

Intervention name(s): Cefazolin; saline
Intervention type(s): Drug; Other
Intervention description(s): Cefazolin 2 gm administered in 100 mL normal saline (after skin sensitivity testing) 15-30 minutes before the start of the procedure. Clindamycin 900 mg to be administered if sensitivity detected to cefazolin.; 100 mL normal saline 15-30 minutes before the start of the procedure
Other intervention name(s): Clindamycin
Intervention MeSH terms: Clindamycin; Cefazolin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: thoracoscopy; pleuroscopy; antibiotic prophylaxis; pleural effusion
BRAVE-DREAMS (BRAin VEnous DRainage Exploited Against Multiple Sclerosis)
Condition: Multiple Sclerosis; Venous Insufficiency
MeSH terms: Multiple Sclerosis; Venous Insufficiency; Sclerosis
Study type: Interventional

Summary: 
      To assess in a double blinded randomized control trial (RCT) study design safety and
      effectiveness of balloon angioplasty of the main extracranial and extravertebral veins in
      multiple sclerosis (MS) associated to chronic cerebrospinal venous insufficiency (CCSVI).

      Mean follow-up 1 year. 5-8 Italian centres 360 relapsing remitting (RR) MS patients will be
      randomized, with expanded disability disease scale (EDSS) ranging 2-5.5, age 18-65.
    

Detailed description: 
      Safety will be assessed by measuring serious and minor adverse effects related to treatment.

      Effectiveness will be assessed by measuring 2 primary endpoints:

        1. Clinical parameters will be expressed in an integrated functional measure leading to the
           score, respectively, of improved, stable, worsened. Functional assessment is performed
           by tools permitting a quantification and will be made by a team of independent
           assessors. Clinical instrumental evaluation will be performed at baseline, and
           subsequently on 3 months basis. The outcome parameters leading to the composite
           functional measure are instrumental parameters, less assessor dependent, singularly
           validated for measuring the disability in MS. They are the followings: A) Dynamic
           Balance Assessment: Balance Master Limits of Stability (LOS). In static platform,
           swinging to reach the set position of center of pressure. B) Walking Function: The
           subject walks spontaneously for 10 meters with chronometric measure of time counting the
           number of steps. The test calculates the walk ratio i.e. ratio between length and step
           frequency. C) Manual dexterity. Box & Block test, moving wooden cubes. D) Sphincter
           control: Post-voiding residual by ultrasounds. F) Visual acuity: Low-contrast visual
           acuity Sloan Letter Chart.

        2. Magnetic Resonance Imaging (MRI) outcome measures: T1Gad active lesion.T2 lesion volume
           MRI evaluation at baseline, 6, 12 months.

      Secondary endpoints are: EDSS, chronic fatigue, cognitive function, rate of restenosis,
      annualized relapse rate.
    

Intervention name(s): Venous PTA; Catheter Venography
Intervention type(s): Procedure; Other
Intervention description(s): PTA of the internal jugular and/or azygous vein; The patients will undergo catheter venography but not PTA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple sclerosis; Chronic cerebrospinal venous insufficiency; Percutaneous Transluminal Angioplasty (PTA); Internal jugular vein; Azygous vein
Antibacterial Effect of Paradontax Toothpaste
Condition: Plaque Induced Gingivitis; Plaque, Dental
MeSH terms: Gingivitis; Dental Plaque
Study type: Interventional

Summary: 
      The purpose of the study is to test the antibacterial effect of Parodontax toothpaste on
      plaque formation, and thus gingivitis compared to placebo toothpaste.

      Each subject will be given 2 plastic splints that are individually adapted to their quadrant
      1 and 2. In the splint in the 1st quadrant, Parodontax test toothpaste will be placed, while
      in the splint in the 2nd quadrant, regular toothpaste will be placed, which the subject uses
      daily. Each person's set of teeth is otherwise professionally cleaned.
    

Detailed description: 
      Each subject will be given 2 plastic splints that are individually adapted to their quadrant
      1 and 2. In the splint in the 1st quadrant, Parodontax test toothpaste will be placed, while
      in the splint in the 2nd quadrant, regular toothpaste will be placed, which the subject uses
      daily. Each person's teeth is otherwise professionally cleaned.

      Home procedure: The subject first rinses the mouth with water for 30 sec. Then both splints
      are placed on the teeth in the 1st quadrant and 2nd quadrant, respectively, and the rest
      (lower jaw) is brushed with the subject's regular toothpaste. The brace should be on for 1
      min while cleaning the teeth in the lower jaw as usual, with its usual commercial toothpaste.
      After 1 minute, rinse your mouth with water for 30 seconds. Then the splints are removed and
      the mouth is immediately rinsed with water for another 30 sec. The procedure is repeated
      twice a day (morning and evening) for 3 weeks (21 days). In this way, the test person becomes
      his own control (1st quadrant versus 2nd quadrant), and the individual plaque quality is
      subordinate to what it would not otherwise be in a 2-group study. Furthermore, individual
      brushing technique will not be an issue, as we only test the antibacterial effect of the
      toothpaste in the splint quadrants. It is the antibacterial effect of Parodontax we test, not
      affected by brushing technique.

      Health information that includes age, medication use, allergies, diseases, and tobacco use.
      Following the test period, registration of plaque (Silness&Loe/Quigley&Hines) and gingival
      bleeding (Loe&Silness) will be registered
    

Intervention name(s): Toothpaste; Paradontax
Intervention type(s): Other
Intervention description(s): Comparison of Paradontax toothpaste anti-plaque abality versus regular toothpaste
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Split mouth
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: split mouth; chemical plaque control