bioihbjkbjnl/mcl2 huggingface dataset:
50% Effective Concentration of Sevoflurane for Immobility
Condition: Anesthetics, Inhalation
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      Sevoflurane is as attractive inhalation agent fore deep sedation in children undergoing short
      invasive procedure because of lack of irritation to the respiratory tract, a pleasant odor
      and rapid clinical effect and recovery due to low blood gas partition coefficient.

      The aim of this study is to determine the optimum inspired concentration of sevoflurane
      required for immobility during botulinum toxin injection in spontaneously breathing children
      with cerebral palsy.
    

Detailed description: 
      All anesthetics were administered by a single experienced anesthesiologist. Anesthetic
      induction was performed progressively with inhaled 1-8% sevoflurane, if the patient was
      cooperative, otherwise directly to the 8%, and subsequent maintenance 2% in oxygen at 5 L
      /min. A face mask was connected to a Mapleson C circuit for it. Patients breathed
      spontaneously, unaided, via a pediatric face mask. A failure was defined as the patient
      continued to move after following the study protocol for sevoflurane inhalation. Insufficient
      sedation was treated with increments of 0.5% concentration to achieve the desired effect, ie,
      maintenance of immobility during botulinum toxin injection. The sevoflurane concentration in
      the next patient would be adjusted depending on the success or failure for immobility at
      given sevoflurane concentration ( if successful, 0.5% lower concentration, if failed, 0.5%
      higher concentration).

      The child was recovered from sevoflurane sedation at the end of botulinum toxin injection and
      transferred to post-anesthetic care unit.
    

Intervention name(s): children receiving sevoflurane
Intervention type(s): Drug
Intervention description(s): Children receiving pre-determined sevoflurane concentration using modified Dixon's up-and-down method
Intervention MeSH terms: Sevoflurane
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sevoflurane; Motion; Botulinum toxins; Cerebral palsy
Subconjunctival Bevacizumab and Recurrent Pterygium
Condition: Recurrent Pterygium
MeSH terms: Pterygium; Recurrence
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      A study to research whether subconjunctival bevacizumab injection may potentially suppress
      neovascularization in pterygium, retarding and decreasing the size of recurrent pterygium.
    

Detailed description: 
      1. Pacients with recurrent pterygium

        2. Anti-VEGF therapy -Bevacizumab
    

Intervention name(s): Bevacizumab
Intervention type(s): Drug
Intervention description(s): One subconjunctival aplication of Bevacizumabe 0,5ml
Other intervention name(s): Avastin
Intervention MeSH terms: Bevacizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Subconjunctival Bevacizumab; Recurrent pterygium
CISBAR Intervention for Social Communication After ABI
Condition: Brain Injuries
MeSH terms: Brain Injuries
Study type: Interventional

Summary: 
      This was the first trial of a new intervention, Collaborative Interpersonal Strategy Building
      with Audio Reflection (CISBAR), for improving social communication in adults following brain
      injury. When developing CISBAR, I aimed to provide speech-language pathologists (SLPs) with
      an integrated package for goal-setting and treatment of social communication after ABI by
      combining motivational interviewing and goal attainment scaling with evidence-based treatment
      elements drawn from social cognitive and conversational coaching approaches. To elicit the
      targeted communication behaviors, CISBAR adds a new system of selecting equivalent
      conversation topics. To foster self-awareness and reflection, CISBAR incorporates the
      Conversational Rating System for ABI (CoRS-ABI). I used a single-case experimental,
      multiple-probe design across participants to evaluate CISBAR.
    

Detailed description: 
      This was the first trial of a new intervention, Collaborative Interpersonal Strategy Building
      with Audio Reflection (CISBAR). CISBAR aims to provide speech-language pathologists (SLPs)
      with an integrated package for goal-setting and treatment of social communication after ABI
      by combining motivational interviewing and goal attainment scaling with evidence-based
      treatment elements drawn from social cognitive and conversational coaching approaches. To
      elicit the targeted communication behaviors, CISBAR adds a new system of selecting equivalent
      conversation topics. To foster self-awareness and reflection, CISBAR incorporates the
      Conversational Rating System for ABI (CoRS-ABI).
    

Intervention name(s): Collaborative Interpersonal Strategy Building with Audio Reflection (CISBAR)
Intervention type(s): Behavioral
Intervention description(s): CISBAR incorporates collaborative, individualized goal-setting, metacognitive strategy training, audio feedback, reflection, and practice, integrated with the Conversational Rating System for ABI (CoRS-ABI) and adding a new method for selecting individualized and equivalently challenging conversation practice topics.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase II Study of Anlotinib in Patients With Advanced Non-small Cell Lung Cancer（ALTER0302）
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug
      Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing
      Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with
      multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit. It has the obvious resistance
      to new angiogenesis. The trial is to explore Anlotinib for the effectiveness and safety of
      andvanced non-small cell lung cancer who failed two lines of chemotherapy
    


Intervention name(s): Anlotinib; Placebo capsule
Intervention type(s): Drug; Drug
Intervention description(s): Anlotinib QD po.; Placebo QD po.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: lung; Anlotinib; AL3818; NSCLC; Cancer
Efficacy of Topical Cysteamine in Nephropathic Cyctinosis
Condition: Nephropathic Cyctinosis; Corneal Cystine Crystals
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the efficacy of topical cysteamine eye drops in the
      treatment of corneal cystine crystals deposits in patients with nephropathic cystinosis.
    

Detailed description: 
      A total of 26 patients with nephropathic cystinosis were included in this prospective study.
      Patients were evaluated for improvement of corneal cysteine deposits crystals and photophobia
      following treatment with topical 0.55% cysteamine eye drops.
    

Intervention name(s): Cysteamine
Intervention type(s): Drug
Intervention description(s): Patients were asked to use topical cysteamine 0.55% eye drops every 2 hours while awake to both eyes.
Intervention MeSH terms: Cysteamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cysteamine; nephropathic cystinosis; cystine crystals
Bileacid Malabsorption and GLP-1 Secretion
Condition: Bileacid Malabsorption
MeSH terms: Malabsorption Syndromes
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to examine the influence of BAM on postprandial GLP--1 secretion and
      glucose homeostasis, both with and without bile acid sequestration.
    


Intervention name(s): "cholestagel®" (Colesevelam); Placebos
Intervention type(s): Drug; Drug
Intervention description(s): 3750mg; 3750mg
Intervention MeSH terms: Colesevelam Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With(J-M-Pa-Z) (NC-001)
Condition: Pulmonary Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Study type: Interventional
Phase: Phase 2

Summary: 
      The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral
      administration of TMC207 alone, TMC207 with pyrazinamide, TMC207 with PA-824, PA-824 with
      pyrazinamide and PA-824 with moxifloxacin and pyrazinamide, as determined by the rate of
      change of log CFU in sputum over the time period Day 0-14 in participants with smear positive
      pulmonary tuberculosis (TB). A control group will receive standard treatment.
    


Intervention name(s): PA-824; Pyrazinamide; TMC207; Rifafour; Moxifloxacin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 200 mg tablet, once daily for 14 days; Dosed by Weight; TMC207 700 mg Day 1; 500mg Day 2; 400mg Days 3-14; Rifafour e-275; moxifloxacin 400 mg
Intervention MeSH terms: Moxifloxacin; Pyrazinamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tuberculosis; EBA; TMC207; pretomanid; Early Bactericidal Activity; Pulmonary Tuberculosis; PA-824; bedaquiline; pyrazinamide; moxifloxacin; ethambutol; rifafour
First in Man Experience With a Drug Eluting Stent in De Novo Coronary Artery Lesions
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A prospective, single-treatment, multi centre clinical trial enrolling 30 patients in 2
      centres in Romania, with a clinical and angiographic follow-up at 4 and 9 months to determine
      the primary endpoint of late lumen loss and secondary endpoints. A subgroup of 15 patients
      will also undergo post implantation, 4 and 9 months IVUS examinations. Additional clinical
      follow-ups take place at 1 month and yearly up to three (3) years.

      The objective of this trial is to assess the safety and clinical performance of the ORSIRO
      drug eluting stent in patients with single de-novo coronary artery lesions.
    


Intervention name(s): ORSIRO - Drug Eluting Coronary Stent
Intervention type(s): Device
Intervention description(s): The coronary stent is delivered to the intended implantation location by means of the fast-exchange delivery system and then expanded to its final diameter by dilating the balloon. It remains in the vessel as a permanent implant.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Improving the Outcomes of Community-based Management of Acute Malnutrition
Condition: Severe Acute Malnutrition
MeSH terms: Malnutrition; Severe Acute Malnutrition
Study type: Observational

Summary: 
      Severe acute malnutrition (SAM) affects 16 million children at any one time and is
      responsible for the deaths of over 500,000 children under 5 years of age each year. Treatment
      for severe acute malnutrition is based on the Community-based Management of Acute
      Malnutrition (CMAM) model. The current methods used for detecting high risk children have not
      prevented 5% mortality observed in regions using this program. The purpose of the study is to
      provide evidence that objective methods for detecting high risk children can be used to
      optimize efficiency of Community-based Management of Acute Malnutrition (CMAM) treatment
      programs and thus improve child health outcomes.
    

Detailed description: 
      A prospective observational study in inpatient care within community-based management of
      acute malnutrition(CMAM) program run by the nongovernmental organization called Alliance for
      International Medical Action (ALIMA) within the University of Maiduguri Teaching Hospital,
      Maiduguri, Nigeria

      The objectives of the study are to validate the BedsidePEWS scores as a measure of severity
      of illness in children who are treated as inpatients for severe acute malnutrition and to
      compare the BedsidePEWS scores with other risk factors associated for mortality and relapse
      of children with severe acute malnutrition. The design is a prospective observational study
      of 1000 children admitted as inpatients in a CMAM program in Maidaguri Teaching Hospital in
      Maidaguri, Nigeria. Data collection (estimated duration 4-5 months) involves vital signs, and
      risk factor assessment every 12 hours for duration of hospitalization. Blood test for
      hemoglobin and malaria will be done once upon admission. Outcomes will be measured every 12
      hours and include mortality and/or escalation and de-escalation of care. Logistic regression
      with significance testing will be used to compare BedsidePEWS scores and risk factors between
      patients and among individual patients within the outcome categories. Exploratory sensitivity
      analyses will repeat the main logistic regression analyses to evaluate the performance of
      partial BedsidePEWS score in patients with missing data of 1-3 of the 7 components, by
      randomly removing 1-3 data elements from the score calculation from patients, and by removing
      systolic blood pressure from scoring.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children between 1-59 months with severe acute malnutrition admitted into inpatient care
        within CMAM program run by the non-governmental organization called Alliance for
        International Medical Action (ALIMA) within the University of Maiduguri Teaching Hospital,
        Maiduguri, Nigeria
Pioglitazone for the Treatment of Bipolar Disorder and Comorbid Metabolic Syndrome or Insulin Resistance
Condition: Metabolic Syndrome; Bipolar Depression; Insulin Resistance
MeSH terms: Metabolic Syndrome; Insulin Resistance; Syndrome; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is an open-label 8-week adjunctive trial of pioglitazone for the acute relief of
      bipolar depression comorbid with metabolic syndrome/insulin resistance. Subjects who
      experience a partial or full response will have the option of continuing in an acute
      continuation phase lasting up to 12 weeks. The extension phase will allow assessment of the
      safety and tolerability of pioglitazone during the acute continuation period.
    


Intervention name(s): Pioglitazone
Intervention type(s): Drug
Intervention description(s): An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
Other intervention name(s): Actos
Intervention MeSH terms: Pioglitazone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study on the Predictive Value of the Natural Calcium Isotope Ratio in Urine and Serum for the Diagnosis of Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Observational

Summary: 
      The study aims at investigating whether the natural calcium isotope ratio (δ44/40Ca) in urine
      and serum differs between postmenopausal women aged 50 to 75 years suffering from
      osteoporosis and a healthy control group and whether δ44/40Ca in urine and serum can be used
      for the diagnosis of osteoporosis or whether further parameters have to be included.
    

Detailed description: 
      According to the operational definition of WHO in the year 1994 osteoporosis is present if
      bone mineral content as assessed by DXA densitometry of the lumbar spine and/or proximal
      femur (total area or femoral neck) deviates from the mean of a 20 to 29 years old women by at
      least -2.5 standard deviations (DXA T-Score ≤ -2.5). This definition of osteoporosis is only
      valid after exclusion of other disorders, which may be associated with a reduction of bone
      mineral content and exclusion of osteomalacia.

      By an individual screening 100 women will be included in the study who are characterized
      concerning existing or non-existing osteoporosis according to the guidelines of DVO 2014 and
      ISCD 2015, respectively.

      According to the EPOS study results the prevalence of osteoporosis in Germany in
      postmenopausal women aged 50 to 60 years is about 15% and at the age of more than 70 years
      about 45%. In case of risk factors, such as hip fracture of father and/or mother, smoking,
      lactose intolerance, vegan nutrition, underweight (BMI < 20), diabetes, intake of loop
      diuretics, glucocorticoids, aromatase inhibitors and proton pump inhibitors a higher
      prevalence can be assumed. Thus by electing women with at least one risk factor of
      osteoporosis a higher proportion may meet the criteria of osteoporosis.

      Since some women are expected to present with low vitamin D levels and so far are expected to
      present with osteomalacia, and since other exclusion criteria may occur, N = 100 women will
      be investigated, in order to obtain data from N = 80 women who may meet the criteria of the
      target group (about N = 40 with osteoporosis and about N = 40 without osteoporosis (normal
      control).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        100 postmenopausal women aged 50- 75y having a risk for osteoporosis should be enrolled in
        the study
      
Biospecimen description: 
      serum sample, plasma sample, urine sample, stool sample
    
Keywords: risk factors; Calcium isotopes; calcium turnover; DXA
Dose Ranging Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Topical Cream in Participants With Mild or Moderate Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being conducted to provide data on efficacy, safety, tolerability and PK of
      multiple topical formulation concentrations of PF-06700841 topical cream in the treatment of
      mild to moderate atopic dermatitis (AD). The study is intended to enable selection of the
      dose and dosing regimen (once daily [QD] vs twice daily [BID] application) for the future
      clinical development of topical PF-06700841.
    


Intervention name(s): PF-06700841; Vehicle (Placebo)
Intervention type(s): Drug; Drug
Intervention description(s): PF-06700841 topical cream; Vehicle topical cream
Intervention MeSH terms: PF-06700841
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mild-to-Moderate Atopic Dermatitis; topical
18670 - Sun Protection Factor Assay
Condition: Sunscreening Agent
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): Coppertone (BAY987518)
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Number - SR15-72_V27-010).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Early Rehab With VR for First-time Acute Stroke
Condition: Stroke, Acute; Acute Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional

Summary: 
      The goal of this clinical trial is to confirm the efficacy and feasibility of early
      rehabilitation combined with virtual reality training in patients following first-time acute
      stroke. The main questions it aims to answer are:

        -  The impact of virtual reality training on muscle strength;

        -  The impact of virtual reality training on functional recovery;

        -  The impact of virtual reality training on mood state.

      Researchers will compare the experimental group, which received early rehabilitation combined
      with VR training, and the comparison group, which received only early rehabilitation, to see
      if VR training has clinical benefits when provided alongside early rehabilitation during
      hospitalization.
    

Detailed description: 
      Early rehabilitation has been shown to enhance outcomes for patients with first-time acute
      stroke. However, whether the addition of virtual reality (VR) training could further improve
      muscle strength, functional recovery, and mood state for these patients is unknown.
      Therefore, this study aimed to investigate the effectiveness of early rehabilitation combined
      with VR training in patients following first-time acute stroke. Patients with acute ischemic
      stroke will be selected and randomly assigned with a 1:1 randomization ratio to either the
      experimental group or the comparison group. Both groups received early rehabilitation, and
      the experimental group received extra VR training starting 24 hours to 3 days poststroke
      during the stay in the hospital. Muscle strength, functional status, and mood state will be
      collected before and after the intervention.
    

Intervention name(s): virtual reality training; early rehabilitation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The experimental group received five additional days of supervised VR training using a wireless sensor in a private room in the neurological care ward.; Five 60-minute sessions per week, was prescribed by a rehabilitation physician and performed by physical, occupational, and speech therapists from 3 to 6 days after admission.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were divided into two groups: the experimental group, which received early rehabilitation combined with VR training, and the comparison group, which received only early rehabilitation.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Early rehabilitation; Virtual reality