bioihbjkbjnl/mcl2 huggingface dataset:
Phase IV Clinical Trial, Immunogenicity and Safety of EV71 Vaccine
Condition: Hand, Foot and Mouth Disease
MeSH terms: Foot-and-Mouth Disease; Hand, Foot and Mouth Disease; Mouth Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the immunogenicity and safety of EV71 vaccine in
      infants aged 6 to 35 months old, by detecting the dynamic changes of neutralizing antibody at
      different time after vaccination
    

Detailed description: 
      This study is an open-labelled, single-centered, stratified-randomized, phase IV clinical
      trial. The purpose of this study is to evaluate the immunogenicity and safety of EV71 vaccine
      (developed by Sinovac Biotech Co., Ltd.) in infants aged 6 to 35 months old, by detecting the
      dynamic changes of neutralizing antibody at different times after vaccination. The enrolled
      subjects in this study receive two doses of EV71 vaccine with 1-month interval between doses.
      To evaluate safety of the vaccine, subjects will be observed for 30 days after the injection
      for the potential adverse events. To evaluate the immunogenicity of the vaccine, venous blood
      will be collected for the neutralizing antibody detection prior to vaccination, 10/20/30 days
      after the 1st dose and 30 days after the 2nd dose vaccination. All subjects will receive
      blood sampling for three times. Subjects will be randomly assigned to receive blood sampling
      at 10/20/30 days after 1st dose injection, with a ratio of 1: 1: 1.
    

Intervention name(s): EV71 vaccine
Intervention type(s): Biological
Intervention description(s): Two doses vaccination of EV71vaccine (Intramuscular injection, 0.5ml) with a schedule of 0, 28 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Inactivated Enterovirus Type 71 (EV71) Vaccine; Safety; Immunogenicity; Infant
A Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus LABA
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to characterize the safety profile of benralizumab
      administration in asthma patients who have completed one of the three predecessor studies:
      D3250C00017, D3250C00018 or D3250C00020.
    

Detailed description: 
      After a minimum of 1200 patients have been enrolled in this study, subsequent patients (up to
      a maximum of 2200 total for the study), who complete a minimum of 16 weeks, and no more than
      40 weeks, in this study, will be given the option to transition to an open-label safety
      extension study, Study D3250C00037 (MELTEMI).

      Adolescent patients, patients from Japan and South Korea, and any patient who chooses not to
      enter Study D3250C00037 will remain in this study through IPD or EOT and FU.

      At the time of the first interim analysis in Japanese patients, the study regimen for all
      patients will become unblinded to AstraZeneca for data analysis purposes. Study conduct and
      blinding at the site and patient level will remain unchanged.
    

Intervention name(s): Benralizumab; Benralizumab
Intervention type(s): Biological; Biological
Intervention description(s): Benralizumab administered subcutaneously; Benralizumab administered subcutaneously
Intervention MeSH terms: Benralizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive Lung Diseases
Caffeine Disposition After Inhalation
Condition: Healthy
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      The purpose of this study is to determine how fast caffeine gets into your body with a
      product called Aeroshot™. Aeroshot™ is a lipstick sized device that you slide open and then
      put your mouth over the opening and inhale. A fine powder containing 100 mg of caffeine is
      deposited on your tongue and the inside of your mouth. Caffeine will be absorbed through the
      membranes in your mouth or swallowed and then absorbed in your stomach. We will compare the
      absorption of caffeine after using the Aeroshot™ with the absorption after drinking an energy
      drink by taking 15 blood samples over 8 hours and measuring the caffeine levels in your
      blood. You will also be asked to fill out some scales to measure the effects you feel after
      the caffeine dose. We hypothesize that caffeine absorption after inhalation will be faster
      than after an energy drink.
    


Intervention name(s): Caffeine
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: caffeine; pharmacokinetics; pharmacodynamics
A Phase 2 Study of CIM331 for Atopic Dermatitis Patients
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the safety, tolerability and efficacy of CIM331, compared to placebo, in atopic
      dermatitis patients who are inadequately controlled by or intolerant to topical therapy
    


Intervention name(s): nemolizumab (CIM331); Placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pharmacokinetics of XueBiJing in Patients With Sepsis
Condition: Sepsis; Septic Shock; Community Acquired Pneumonia
MeSH terms: Sepsis; Toxemia; Shock, Septic
Study type: Interventional

Summary: 
      Pharmacokinetics and disposition of XueBiJing compounds in patients with sepsis
    

Detailed description: 
      XueBiJing injection, a five-herb combination approved by Chinese FDA in 2004, has been widely
      used as an add-on therapy in routine sepsis care in Chinese clinics. A comprehensive
      pharmacokinetic research on this herbal injection has been conducted in healthy human
      subjects, and the major circulating XueBiJing compounds, as well as their systemic exposure
      levels and forms and pharmacokinetic characteristics, have been identified. However, it is
      known that sepsis may induce hepatic, renal and cardiac dysfunction, alter drug metabolizing
      enzymes and transporters activities, increase capillary permeability, and induce various
      pathophysiological changes. All these will affect the concentrations at the action sites and
      pharmacokinetic characteristics of XueBiJing compounds, which contribute to the injection's
      overall therapeutic action, thus influencing the anti-septic efficacy of the injection. The
      purpose of this prospective, open label study is to identify the circulating XueBiJing
      compounds in patients with sepsis after intravenously dosing XueBiJing injection and their
      systemic exposure forms and levels, pharmacokinetic characteristics, and the associated
      inter-patient differences of these XueBiJing compounds.
    

Intervention name(s): XueBiJing injection
Intervention type(s): Drug
Intervention description(s): 100mL XueBiJing injection (dissolved with 100 mL of 0.9% normal saline),intravenous infusion for 1.25 h, q12h for 5 days
Other intervention name(s): Tianjin Chase Sun Pharmaceutical Co. LTD
Intervention model: Single Group Assignment
Intervention model description: 100mL XueBiJing injection (dissolved with 100 mL of 0.9% normal saline),intravenous infusion for 1.25 h, q12h for 5 days
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: XueBiJing injection; Sepsis; Septic shock; Pharmacokinetics
Safety and Pharmacokinetics of Nicotinamide Mononucleotide (NMN) in Healthy Adults.
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the safety, pharmacokinetic profile, and effects
      of nicotinamide mononucleotide (NMN-C) in healthy adults, 18-65 years of age. The effects
      will be studied over the course of 30 days in a repeated-dose study through the collection of
      blood and urine samples, and administration of surveys and questionnaires.
    


Intervention name(s): Nicotinamide mononucleotide (NMN-C)
Intervention type(s): Dietary Supplement
Intervention description(s): Daily supplementation with NMN-C at 400 mg for 29 days in total
Intervention MeSH terms: Niacinamide; Niacin; Nicotinic Acids
Intervention model: Single Group Assignment
Intervention model description: A single-arm, non-randomized, non-controlled, monocenter repeated-dose study
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: safety; pharmacokinetics
The Safety of Vardenafil in Patients Undergoing Cardiac Surgery
Condition: Ischemia-reperfusion Injury.
MeSH terms: Reperfusion Injury; Ischemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety of vardenafil in cardiac surgery
      patients.
    


Intervention name(s): Vardenafil
Intervention type(s): Drug
Intervention description(s): 10 mg PO once
Intervention MeSH terms: Vardenafil Dihydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Case-control Study of Sleep Disorders in Children With Cystic Fibrosis
Condition: Cystic Fibrosis; Sleep Disorder
MeSH terms: Cystic Fibrosis; Sleep Wake Disorders; Parasomnias; Fibrosis
Study type: Observational

Summary: 
      Our primary purpose is to compare the prevalence of sleep disorders in children aged 6 to 17
      with cystic fibrosis versus controls with a Sleep disorder screening score, the SDSC. Our
      hypothesis is that patients aged 6 to 17 with cystic fibrosis have a higher prevalence of
      sleep disturbances than the general population of the same age group.

      Our secondary hypothesis is that these sleep disorders are mixed and that there are
      non-respiratory causes, sometimes modifiable by simple non-medical treatment and that's why
      our secondary purpose is to identify the responsible factors, in particular non-respiratory
      factors in the 2 groups and to compare them.
    


Intervention name(s): Questionnaire
Intervention type(s): Behavioral
Intervention description(s): Questionnaire submitted to the parents of children with cystic fibrosis aged 6 to 17 years and to controls in order to assess and compare the prevalence of sleep disorders and their main non-respiratory causes
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children from 6 to 17 years with cystic fibrosis for the case group and children with an
        emergency surgical consultation for the control group
      
Keywords: Children; Case control study
The Effect of Music in Alzheimer's Patients
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      This study was randomized controlled study conducted to determine the effect of Nihavent
      theme on reducing adjustment difficulties in Alzheimer's patients.

      The study was carried out with 30 patients.15 patients constituted the experimental group and
      15 patients formed the control group. Before the application, the scale was administered to
      both groups through face-to-face interviews. The patients in the experimental group were
      informed about the music session in advance.Instrumental songs in nihavent theme were played
      with the sound system to the experimental group. The sessions were lasted 12 weeks in total
      and there were two sessions per week, and each session took approximately 50 minutes to
      complete. While no intervention was performed for the patients in the control group. One week
      after the last music session, the the scale was re-administered to both groups.
    

Detailed description: 
      Adaptation levels of Alzheimer's patients should be determined before planning nursing
      interventions. Institutions should support healthcare personnel in organizing music sessions
      for patients. It is believed that further studies examining the effect of the Nihavent theme
      in decreasing adaptation difficulty in Alzheimer's patients should be conducted with larger
      sample groups. The effects of verbal and non-verbal music on Alzheimer's patients should also
      be evaluated and compared to gain further insight on this important matter.
    

Intervention name(s): Music therapy
Intervention type(s): Other
Intervention description(s): rutin
Other intervention name(s): rutin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Supportive Care
Keywords: Alzheimer's disease; Music; Adaptation difficulty; Nursing care
Targeted Internal Radiation Therapy in Advanced HCC Patients.
Condition: Internal Radiation; Advanced Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the 131I-chTNT-1/B treatment effect and safety of
      individual therapy using randomized controlled study, in order to acquire the evidence of
      evidence-based medicine and create a new program of targeted internal radiation therapy in
      advanced HCC patients.
    


Intervention name(s): 131I-chTNT-1/B
Intervention type(s): Biological
Intervention description(s): 29.6 MBq/kg,intravenous administration in 1 hour，1-3 course of treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 131I-chTNT-1/B treatment
Cryosurgery in Treating Patients With Unresectable Liver Metastases From Colorectal Cancer
Condition: Colorectal Cancer; Metastatic Cancer
MeSH terms: Colorectal Neoplasms; Neoplasm Metastasis
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Cryosurgery for liver metastases may have fewer side effects and improve recovery.

      PURPOSE: Phase II trial to study the effectiveness of cryosurgery for patients with
      unresectable liver metastases from colorectal cancer.
    

Detailed description: 
      OBJECTIVES: I. Evaluate the feasibility of conducting a multi-institutional clinical study of
      cryosurgery for liver metastases. II. Evaluate the morbidity and mortality of cryosurgery for
      liver metastases when applied in a multi-institutional setting. III. Evaluate the efficacy of
      cryosurgery for liver metastases as measured by total liver control, local lesion control,
      and overall survival.

      OUTLINE: This is a multi-institutional study. Patients are first confirmed by exploratory
      laparotomy to have no extrahepatic metastases. They then undergo biopsy of the portal lymph
      node, after which, full mobilization of liver is recommended. Cholecystectomy is optional but
      recommended for treatment of tumors adjacent to the gallbladder. After mapping out the
      location and size of the metastatic tumor by ultrasound, cryoablation of the metastases is
      carried out. Cryoablation involves the delivery of nitrogen through metallic probes placed
      surgically into the center of the liver metastases. There are two freeze and thaw cycles for
      each lesion with synchronous intraoperative ultrasound monitoring of the cryoablation. One
      centimeter margin of cryoablation is determined by this ultrasound image. Treatment of the
      liver with regional chemotherapy is not allowed until radiographic and pathologic
      confirmation of disease progression in the liver. Follow-up is at 3 weeks after surgery and
      then every 3 months.

      PROJECTED ACCRUAL: There will be a maximum of 45 patients accrued in approximately 3 years
      for this study. This is a two stage accrual design in which 17 patients are first accrued of
      which 15 should be eligible. If fewer than 11 of the initial 15 eligible patients show no
      evidence of disease at 3 months, the study stops and treatment is abandoned. If at least 11
      patients show no evidence of disease, then 28 additional patients are accrued.
    

Intervention name(s): cryosurgery
Intervention type(s): Procedure
Primary purpose: Treatment
Keywords: stage IV colon cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer; adenocarcinoma of the colon; adenocarcinoma of the rectum; liver metastases
Evaluation of Immunogenicity and Safety of the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus (DPT-IPV) Vaccine Squarekids Co-administered With GSK Biologicals' Human Rotavirus (HRV) Vaccine Rotarix (GSK444563) in Healthy Infants
Condition: Rotavirus
MeSH terms: Whooping Cough; Tetanus; Diphtheria
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the immunogenicity and safety of the diphtheria,
      tetanus, pertussis and inactivated poliovirus (DPT-IPV) vaccine Squarekids administered with
      or without the GSK Biologicals' liquid Rotarix (HRV) vaccine, in healthy Japanese infants
      aged 6 - 12 weeks. GSK Biologicals' liquid HRV vaccine Rotarix is licensed in Japan since
      2011. Although the concomitant administration of GSK Biologicals' DTP-IPV vaccine has been
      evaluated during the clinical development of the HRV vaccine, the vaccine differed in
      composition and route of administration from the DPT-IPV vaccine Squarekids manufactured in
      Japan. Hence, as requested by the Japanese regulatory authorities, this post-licensure study
      will evaluate the immunogenicity of the DPT-IPV vaccine manufactured in Japan when
      co-administered with the liquid HRV vaccine
    

Detailed description: 
      This study is a phase IV, open-label, randomised, controlled, multi-centric, single-country
      study with two parallel groups. Subjects in the co-administration group will be administered
      the DPT-IPV vaccine according to a 3, 4, 6 month schedule and the liquid HRV vaccine
      according to a 2, 3 month schedule. Subjects in the staggered group will be administered the
      DPT-IPV vaccine according to a 3, 4.5, 6 month schedule and the liquid HRV vaccine according
      to a 2, 3.5 month schedule. The intended duration of the study, per subject, is 5 months.

      A sub-cohort of subjects (HRV Immunogenicity sub-cohort) from both the study groups will
      include the first 73 subjects enrolled into the study to assess the serum anti-RV IgA
      seropositivity and Geometric Mean Concentrations (GMC).
    

Intervention name(s): Squarekids; Rotarix
Intervention type(s): Biological; Biological
Intervention description(s): Three doses administered subcutaneously in the upper arm or thigh; Two doses administered orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Healthy Japanese infants; Safety; Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus (DPT-IPV) vaccine; Vaccination; Oral HRV liquid vaccine; Immunogenicity
Effects of Crystal Solution and Colloid Solution on Mother and Fetus
Condition: Cesarean Section; Spinal Anesthesia; Parturition
Study type: Interventional
Phase: Phase 4

Summary: 
      Comparison of the effects of crystal solution (lactic acid Ringer's solution) and colloid
      solution (hydroxyethyl starch) on mother and fetus after cesarean section
    

Detailed description: 
      The Hydroxyethl group use 10 ml/kg hydroxyethl starch as well as goal-directed fluid therapy
      with 3ml/kg hydroxyethl starch. The control group 10 ml/kg Lactated Ringer's solution as well
      as goal-directed fluid therapy with 3ml/kg Lactated Ringer's solution. During the whole
      operation of elective cesarean section
    

Intervention name(s): hydroxyethl starch; Lactated Ringer's solution
Intervention type(s): Drug; Drug
Intervention description(s): 10 ml/kg hydroxyethl starch as well as goal-directed fluid therapy with 3ml/kg hydroxyethl starch; 10 ml/kg Lactated Ringer's solution as well as goal-directed fluid therapy with 3ml/kg Lactated Ringer's solution
Other intervention name(s): Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Clinical Implications of DNA Analysis on ADPKD
Condition: Autosomal Dominant Polycystic Kidney Disease
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Study type: Observational

Summary: 
      Autosomal dominant polycystic kidney disease (ADPKD) is an inherited disease. We plan DNA
      analysis using the next generation sequencer (NGS) and examine the relationship between
      mutational types and clinical phenotypes. The accuracy of DNA analysis with NGS is tested by
      Sanger's method. The kidney and life survival curves will be compared between PKD1, PKD2 and
      non-ADPKD family members.
    

Detailed description: 
      80 unrelated patients with ADPKD attending to the Kyorin University Hospital whose clinical
      data are compiled. DNA analysis is performed at Otsuka Pharmaceutical Laboratory.

      Clinical data include total kidney volume (TKV), TKV slope, eGFR, eGFR slope and other
      clinically relevant data.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The patients with ADPKD visiting Kyorin university hospital over two years. The patients
        whose clinical data including total kidney volume (TKV), eGFR, QOL data and other relevant
        clinical data are available will be enrolled.
      
Biospecimen description: 
      Blood
    
Keywords: Autosomal Dominant Polycystic Kidney Disease; PKD 1 gene; PKD 2 gene; Truncational mutation; Hypomorphic mutation
FES to Improve Crouch Gait in CP
Condition: Cerebral Palsy; Gait
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The overall goal of the proposed work is to develop and to assess the feasibility of using
      functional electrical stimulation (FES) system to improve crouch gait in individuals with
      cerebral palsy that may prevent the typical downward spiral of walking function decline in
      individuals with CP that occurs from adolescence into adulthood.
    

Detailed description: 
      Aim 1: To assess the feasibility of using a multiple channel FES system to produce an
      immediate neuroprosthetic effect to reduce crouch gait in children and adolescents with
      spastic diplegic CP.

      Aim 2: To assess the feasibility of using a multiple channel FES system as a therapeutic
      training tool to produce lasting neurotherapeutic effects of diminished crouch gait in
      children and adolescents with CP.
    

Intervention name(s): Functional Electrical Stimulation.
Intervention type(s): Device
Intervention description(s): Functional electrical stimulation - electrical stimulation applied to a muscle during an activity (i.e. ankle dorsiflexors during swing phase of gait). It assists / elicits muscle activation in order to achieve a task.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cerebral Palsy; Functional electrical stimulation; Neurotherapeutic