bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate Safety, Tolerability, & Immunogenicity of Multiple Formulations of BNT162b2 Against COVID-19 in Healthy Adults
Condition: SARS-CoV-2 Infection; COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare the safety and tolerability of lyophilized BNT162b2 presented in
      single dose vials to those of frozen-liquid BNT162b2 in multidose vials and determine whether
      the immune response is noninferior. Separately, the study will also describe the safety and
      immunogenicity of frozen-liquid BNT162b2 with lipid nanoparticle size at the upper end of
      specification and ready to use BNT162b2 (the immediate manufacturing precursor to the
      lyophilate). Additionally, the study will describe the safety and immunogenicity of an
      additional dose of frozen liquid BNT162b2 to participants who already received the 2-dose
      schedule of lyophilized BNT162b2.

        -  2-dose schedule (separated by 21 days)

        -  At a dose of 30µg (as studied in the Phase 2/3 study C4591001)

        -  In healthy adults 18 through 55 years of age

        -  The duration of the study for each participant will be approximately 2 months (3 visits
           in total)

        -  The study will be conducted in the United States
    


Intervention name(s): BNT162b2
Intervention type(s): Biological
Intervention description(s): Intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: COVID-19; Coronavirus; Vaccine; SARS-CoV-2; RNA Vaccine
A Phase I Clinical Study on SHR6390 in Healthy Chinese Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was to evaluate the pharmacokinetics and safety of SHR6390 at doses of 100 mg, 125
      mg, and 150 mg after process modification in Chinese healthy volunteers. A single oral dose
      of SHR6390 was given to each group, including 100 mg, 125mg and 150mg of SHR6390.
    


Intervention name(s): SHR6390(100mg); SHR6390(125mg); SHR6390(150mg)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SHR6390 at a single oral dose of 100 mg.; SHR6390 at a single oral dose of 125 mg.; SHR6390 at a single oral dose of 150 mg.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Artificial Intelligence in Breast Cancer Screening in Region Östergötland Linkoping
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The purpose of this observational study is to assess whether the use of AI (Transpara®) can
      lead to an improved quality of a double reading mammography screening program. This is
      investigated by performing AI as a third reader and as a decision support during the
      consensus meeting, compared with conventional mammography screening (double reading and
      consensus without AI).
    

Detailed description: 
      The AI cancer detection system will act as a 3rd reader and will recall additional cases to
      the consensus conference: the exams that were not recalled by double reading but are
      classified as the 3% most suspicious exams, based on AI derived cancer-risk scores. Secondly,
      AI is used as a decision support during consensus. AI risk scores and Computer-Aided
      Detection (CAD)-marks of suspicious calcifications and soft tissue lesions are provided to
      the reader(s).

      The hypothesis of this study is that the use of AI has the potential to improve the quality
      of the screening program by increasing the cancer detection rate without affecting the recall
      rate.
    

Intervention name(s): AI cancer detection system
Intervention type(s): Other
Intervention description(s): The use of AI as a third reader and as a decision support system during consensus meeting
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women eligible for population-based mammography screening
      
Keywords: Artificial intelligence
Memantine as Adjunctive Therapy for Schizophrenia Negative Symptoms
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      Memantine as an add-on therapy to clozapine may improve schizophrenia negative symptoms and
      cognitive functioning.
    


Intervention name(s): memantine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): memantine 10mg twice a day; 1 capsule of placebo twice a day
Other intervention name(s): Ebixa; Starch
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; negative symptoms; clozapine
Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated Vasculitis
Condition: Granulomatosis With Polyangiitis; Microscopic Polyangiitis
MeSH terms: Granulomatosis with Polyangiitis; Microscopic Polyangiitis; Vasculitis; Systemic Vasculitis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this pilot study is to test whether an 8-week course of glucocorticoids,
      combined with rituximab, is effective in treating ANCA-associated vasculitis.
    

Detailed description: 
      The primary aim of this pilot study is to examine whether an 8 week course of
      glucocorticoids, in combination with rituximab, is effective in inducing and maintaining
      disease remission for up to 6 months in a subset of patients with ANCA-associated vasculitis
      (AAV) who have a more favorable prognosis.

      This pilot study will enroll 20 patients with active AAV. Close patient follow-up will insure
      that any patients who require courses of glucocorticoids longer than two months will receive
      longer therapy, if appropriate for their well-being.
    

Intervention name(s): Glucocorticoids; Rituximab
Intervention type(s): Drug; Drug
Intervention description(s): Patients will begin prednisone therapy at a dose selected by the investigator or the treating physician with oral prednisone 60mg or 1mg/kg (if weight less than 60kg) or intravenous methylprednisolone, up to 1g/day for three days.
Prednisone will be tapered over 8 weeks as follows:
60mg for 2 weeks
40mg for 2 weeks
30mg for 1 week
20mg for 1 week
10mg for 1 week
5mg for 1 week; Rituximab will be administered in four weekly doses at 375mg/m2
Other intervention name(s): Prednisone; Rituxan
Intervention MeSH terms: Prednisone; Rituximab; Glucocorticoids
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
School-Based Preventive Asthma Care Technology: A Trial Using a Novel Technology to Improve Adherence
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The goal of this new translational project is to test the feasibility and effectiveness of
      implementing school-based directly observed therapy of preventive asthma medications in a
      real-world setting, using state-of-the-art web-based technology for systematic screening,
      electronic report generation, and communication between nurses, caregivers, and primary care
      providers. With the use of a novel method to improve adherence and subsequently reduce
      morbidity, the investigators hypothesize that this novel adaptation of school-based asthma
      care will; 1) be feasible and acceptable among this population and among school and community
      stakeholders, and 2) yield reduced asthma morbidity (symptom-free days, absenteeism, and
      emergency room / urgent care use for asthma care). The investigators anticipate that
      enhancing preventive healthcare for young urban children with asthma through partnerships
      with the schools using a novel technology will yield improved health, prevention of
      suffering, decreased absenteeism from school, and reduced healthcare costs.
    


Intervention name(s): School-Based Medication Delivery
Intervention type(s): Other
Intervention description(s): For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school. If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy. The child's school nurse begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma
Respiratory Motion Related Ablation Gap and Clinical Outcome After Catheter Ablation for Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      This is the evaluation which is associated with apnea symptom, one of the recurrence factors,
      after AF ablation to patients who diagnosed AF.

      This is the evaluation which is associated with excessive respiration exercise during AF
      ablation to patients who diagnosed AF.

      This is the evaluation which is associated with excessive respiration exercise to make a gap
      during AF ablation to patients who diagnosed AF.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Consecutive patients with atrial fibrillation who undergoing catheter ablation in Yonsei
        Cardiovascular hospital, Yonsei university health system, Seoul, Korea.
      
Keywords: Atrial fibrillation, sleep apnea
Tolerability and Immunogenicity Study of Fluval AB Suspension for Injection
Condition: Influenza Prophylaxis
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess immunogenicity of a single intramuscular injection of Fluval AB suspension for
      injection (trivalent, seasonal influenza vaccine, active ingredient content: 15 μgHA/0.5mL of
      seasonal A/H1N1, A/H3N2 and B influenza antigens each), as measured by haemagglutination
      inhibition (HI) test.
    

Detailed description: 
      Aim of the study:

      To assess immunogenicity and safety of Fluval AB seasonal influenza vaccine with 3 x 15 μgHA
      active ingredient in two age groups (18-59 years and ≥60 years) in accordance with
      CPMP/BWP/214/96: "Note for Guidance on Harmonization of Requirements for Influenza Vaccines",
      12 March 1997

      Primary objective:

      To assess immunogenicity of a single intramuscular injection of Fluval AB suspension for
      injection (trivalent, seasonal influenza vaccine, active ingredient content: 15 μgHA/0.5mL of
      seasonal A/H1N1, A/H3N2 and B influenza antigens each), as measured by haemagglutination
      inhibition test.

      Methods:

      In this open label, uncontrolled, multi-centre immunogenicity and tolerability study subjects
      were enrolled in two groups according to age (18-59 years and ≥60 years) and assigned to the
      following vaccine group:

      Group 1: Single injection of Fluval AB suspension for injection. Subjects were observed for
      30 minutes after the injection on Visit 1 (Day 0) for any immediate reactions.

      All subjects were requested to complete a diary card to record local reactions (injection
      site pain, erythema, swelling, induration and ecchymosis) and systemic reactions (fever,
      shivering, headache, malaise, fatigue, sweating, nausea, myalgia and arthralgia) started on
      the day of vaccination on Visit 1 (Day 0) until 7 (seven) days following that.

      All adverse events were collected during the period of Visit 1 (Day 0) to Visit 2 (between
      Day 21 and Day 28).

      Serum samples for immunogenicity assays were collected immediately before immunization on
      Visit 1 (Day 0) and on Visit 2 (between Day 21 and Day 28) in all subjects. Immunogenicity
      was evaluated by HI test.
    

Intervention name(s): Vaccination with Fluval AB suspension for injection
Intervention type(s): Biological
Intervention description(s): Single intramuscular injection with Fluval AB suspension for injection in both age groups
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: parallel-group, in two age groups
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: uncontrolled; open; multi-centre; immunogenicity and tolerability; two groups according to age (18-59 years and ≥60 years)
Remifentanil for the I-gel and Laryngeal Mask Airway Insertion
Condition: Supraglottic Airways for General Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      Structural differences of supraglottic airway devices could influence the different
      compressive forces in the oropharyngeal cavities, and require different depth of anesthesia.
      The addition of remifentanil during propofol anesthesia facilitates the insertion of
      laryngeal mask airway (LMA) with minimal adverse hemodynamic disturbances. This study was
      designed to determine the effect-site concentration of remifentanil in 50% of patients (EC50)
      and 95% of patients (EC95) for successful i- gel insertion, and compare those for LMA
      insertion during propofol target-controlled infusion (TCI).
    

Detailed description: 
      Anesthesia was induced with propofol TCI at the effect-site concentration of 5 μg/ml, and the
      predetermined effect-site concentration of remifentanil was started simultaneously. The
      remifentanil concentration was determined using modified Dixon's up-and-down method (initial
      concentration: 3.0 ng/ml, step size: 0.5 ng/ml). Five minutes later, i- gel or LMA insertion
      was attempted. The response of the patients to the insertion of LMA was classified as either
      'movement' or 'no movement'.
    

Intervention name(s): remifentanil; i-gel; laryngeal mask airway; propofol
Intervention type(s): Drug; Device; Device; Drug
Intervention description(s): The predetermined effect-site concentration of remifentanil was started using modified Dixon's up-and-down method; I-gel insertion was inserted 5 min after anesthesia induction; laryngeal mask airway insertion was inserted 5 min after anesthesia induction; Anesthesia was induced with propofol target-controlled infusion at the effect-site concentration of 5 μg/ml
Other intervention name(s): ultiva; fresofol
Intervention MeSH terms: Remifentanil; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Distraction and Nitrous Oxide for Venous Puncture
Condition: Anxiety; Pain; Venous Puncture
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This study will compare the efficiency of the iPad distraction or the administration of
      Nitrous Oxide on the anxiety decrease when a peripheral venous catheter is needed in children
      between 3 and 9 years old.
    

Detailed description: 
      The study is aiming at demonstrating the efficacy of active distraction by an iPad on the
      anxiety consequent to venipuncture and insertion of a peripheral vein catheter. The
      comparator is nitrous oxide in a 50% mixture with oxygen that is routinely used for sedation
      during procedural pain. However, nitrous oxide has secondary effects particularly on the
      inhibition of Vitamin B12.

      The primary outcome is anxiety scores. Secondary outcomes are pain scores and satisfaction of
      parents and health providers.

      All children will have EMLA cream (mixture prilocaine and lidocaine) applied one hour prior
      to venous punction. Anxiety, pain and satisfaction scores will be recorded at baseline and
      then within an hour following the venipuncture and insertion of the peripheral vein catheter.
    

Intervention name(s): Games on an iPad; Nitrous Oxide
Intervention type(s): Other; Drug
Intervention description(s): Many games will be programmed on the iPad and organized by age. The child will choose one game and play it during all the procedure time.; Nitrous oxide will be provided to the child by a mask 3 minutes before the intervention and during all this one.
Intervention MeSH terms: Nitrous Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized clinical trial
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: nitrous oxide; distraction
Reliability of Different FOT Devices to Measure the Human Respiratory Impedance
Condition: Pulmonary Disease; Healthy
MeSH terms: Lung Diseases
Study type: Observational

Summary: 
      The objective of the study is to evaluate the reliability of the impedance data in adult
      subjects measured with five different FOT devices.
    

Detailed description: 
      The purpose of the study is to evaluate the reliability of the respiratory impedance measured
      with different FOT (=Forced Oscillation Technique) devices. To this end, the respiratory
      impedance of fifty adult subjects will be measured in random order with five different forced
      oscillation devices. As there is no "gold standard" FOT-device, each setup will be compared
      to all other setups.

      Secondary study questions are: 1) is there a specific comfort (or discomfort) associated with
      the different measuring devices 2) Guidelines state that full chin and cheek support should
      be applied when measuring the human respiratory impedance. What is the influence of a partial
      cheek support?
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy adult subjects and patients with obstructibve lung disease
      
Keywords: Respiratory resistance; Respiratory reactance; Adult lung function; Forced oscillation technique; subjects
GlycoCholic Acid Treatment for Patients With Inborn Errors in Bile Acid Synthesis
Condition: Bile Acid Synthesis Defect; Inborn Error of Bile Acid Metabolism; Inborn Error of Bile Acid Conjugation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research study is to determine the way (mechanisms) by which your defect
      in bile acid handling (metabolism) causes your liver disease or abnormality in absorption of
      vitamins and the effect of an investigational bile acid therapy (glycocholic acid) on your
      vitamin absorption and your liver disease. An investigational therapy is one that not
      approved by the United States Food and Drug Administration (FDA) and is being provided to you
      under an Investigational New Drug application from the FDA.
    

Detailed description: 
      Inborn errors of bile acid metabolism have been established as a well recognized cause of
      neonatal cholestasis and fat-soluble vitamin malabsorption. Although there is extensive
      experience with metabolic defects in the biosynthetic pathway, few patients have identified
      with defects in conjugation with taurine or glycine that allows bile acids to become
      effective detergents. This protocol is designed to study the effect of defects of conjugation
      of bile acids on growth and fat-soluble vitamin malabsorption. Study subjects will have liver
      function studies performed, serum and urinary bile acid measurements, vitamin levels, growth
      measurements, bile acid pool size measurements made by stable isotope dilution
      mass-spectrometry, and measurements of absorption of two fat-soluble vitamins, tocopherol and
      vitamin D. Subjects will be treated orally with conjugates of cholic acid with follow-up
      laboratories performed as an outpatient and then subjects will have all of the initial
      studies repeated during an inpatient stay 3-12 months after starting treatment. Subjects with
      previous liver biopsies indicating the presence of significant liver disease will have a
      repeat liver biopsy after 3-12 months treatment to assess the histologic response to
      treatment.
    

Intervention name(s): Glycocholic Acid
Intervention type(s): Drug
Intervention description(s): 10-15mg/kg body weight/day taken orally. Supplied as either liquid or 50mg capsules.
Other intervention name(s): Conjugated Cholic Acid
Intervention MeSH terms: Cholic Acids; Glycocholic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Initialization of Methadone in Primary Care, Randomized Intervention Research for Preventing HCV Transmission Practices
Condition: Hepatitis C; Substance Dependence; Methadone
MeSH terms: Hepatitis C; Substance-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The rapid scale up of opioid substitution treatment (OST) for drug users mainly achieved
      through the possibility of prescribing buprenorphine in primary care has been successful in
      reducing HIV prevalence among drug users but still inadequate for reducing the spread of HCV.
      To date, methadone in France can only be initialised in drug centres but GPs can prescribe
      methadone after stabilisation of dosages.

      This study was born as an answer to a request from the French Minister of Health that
      supports the initialisation of methadone in primary care in order to improve coverage by OST
      (now 70%) in drug users.
    

Detailed description: 
      We aimed to test the non inferiority of the proportion of non users of street-opioids after
      one year of treatment in patients inducted in primary care (PC) vs.those inducted in a
      specialised center for substance dependence (CSAPA).

      In this multisite, open-label, randomised controlled non-inferiority trial, opioid dependent
      individuals were randomized to start methadone either in PC or in a CSAPA. After
      stabilization of methadone dosage (~2 weeks), patients could change arm. Follow-up
      assessments through medical questionnaires and phone interviews was scheduled at month 0 (M0,
      enrolment) M3, M6, M12. The opiate treatment index (OTI) was used for computing the
      proportion of patients reporting no use of street opioids in the last month at M12 (primary
      outcome) in those inducted in PC or in a CSAPA and the non inferiority margins.

      Primary analysis was by intention to treat (ITT)
    

Intervention name(s): Methadone
Intervention type(s): Drug
Intervention description(s): Methadone sirup once daily
Intervention MeSH terms: Methadone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Methadone; Substance Dependence
A Clinical Trial on the Effects of Home-based Five Plus Exercise Training
Condition: Intermittent Claudication
MeSH terms: Intermittent Claudication
Study type: Interventional

Summary: 
      The aim of the study is to evaluate whether walking capacity in patients with intermittent
      claudication is improved more by home-based 5+ exercise training than by current
      recommendations of daily walking. The study will elucidate if such a potential effect is
      dependent on changes in mitochondrial respiratory capacity, blood flow or both.
    


Intervention name(s): Five plus exercise training
Intervention type(s): Other
Intervention description(s): calf raise exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mitochondria, muscle; Exercise; Blood Flow Velocity