bioihbjkbjnl/mcl2 huggingface dataset:
Consistency & Immunogenicity Study of 3 Lots of GSK's Hib Conjugate Vaccine Versus ActHIB & Pentacel in Healthy Infants
Condition: Haemophilus Influenzae Type b
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate safety, to demonstrate lot-to-lot consistency of the
      vaccine, to address the relevant concomitant vaccine administrations and to provide a
      comparison between GSK Biologicals' Hib conjugate vaccine and the licensed monovalent Hib
      vaccine ActHIB as well as the licensed combination product Pentacel in infants at 2, 4, 6 and
      15-18 months of age. This study is designed with a primary and a booster phase.
    

Detailed description: 
      This protocol posting has been updated following protocol amendment 3, dated 12 April 2011.
      The impacted section is: Eligibility Criteria (Exclusion criteria).
    

Intervention name(s): GSK Biologicals' Haemophilus influenzae type b vaccine (GSK 208108); ActHIB™; Pentacel™; Pediarix™; Prevnar 13™; Rotarix™; Engerix™-B; Infanrix™
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Three doses of 3 different manufacturing lots in primary study at 2, 4 and 6 months of age as intramuscular injection and one dose as booster vaccination.; Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection and one dose as a booster vaccination; Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection and one dose as a booster vaccination; Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection; Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection; Two oral doses in primary epoch at 2 and 4 months of age; Two or three doses in primary epoch at 2,( 4) and 6 months of age as intramuscular injection; One dose in the booster epoch at 15-18 months of age as intramuscular injection
Other intervention name(s): Hiberix®
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: primary vaccination course; Haemophilus influenzae type b; infants, children; booster vaccination; immunogenicity; safety; Gram-negative bacterial infections; vaccines, conjugate
Self-control Trial to Evaluate the Remission Rate in Newly Diagnosed Type 2 Diabetes Patients After Treatment With Insulin Aspart
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is conducted in Asia. The aim of this trial is evaluate the remission rate in
      newly diagnosed subjects with type 2 diabetes after short-term intensive treatment with
      insulin aspart and insulin NPH.
    


Intervention name(s): insulin aspart; insulin NPH
Intervention type(s): Drug; Drug
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Isophane Insulin, Human; Insulin, Isophane; Isophane insulin, beef
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Swiss National Iodine Survey 2020
Condition: Healthy
Study type: Observational

Summary: 
      This study will assess iodine status in school aged children and pregnant women is
      Switzerland. In addition, thyroid status and omega-3 index will be assessed in pregnant
      women.
    


Intervention name(s): There is no intervention. It is an observational study.
Intervention type(s): Other
Intervention description(s): There is not intervention
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Both groups: nationally representative sample selected through schools (children) and
        gynecologists (women).

        School aged children: aged between 6 and 12 years Pregnant women: aged between 18 and 44
        years, pregnant
      
Biospecimen description: 
      spot urine samples from women and children, dried blood spots from women.
A Study in Healthy Volunteers and Patients With Chronic Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This two-part, Phase 1 protocol will be the first clinical study of ABI-H0731. Part I will be
      a Phase 1a dose-ranging assessment of ABI-H0731 in healthy adult volunteers. If the
      dose-related safety, tolerability and pharmacokinetics (PK) of ABI-H0731 in human volunteers
      are deemed satisfactory, then the study will advance to Part II, a Phase 1b dose-ranging
      assessment of ABI-H0731 in non-cirrhotic, CHB patients.
    


Intervention name(s): ABI-H0731; Placebo for ABI-H0731; Entecavir; Tenofovir disoproxil fumarate; Pegasys; Nucleos(t)ide
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Used to treat adults with chronic hepatitis B virus; Used to treat adults with chronic hepatitis B virus; Used to treat adults with chronic hepatitis B virus who show signs of liver damage; Used to treat adults with chronic hepatitis B virus
Other intervention name(s): Sugar pill manufactured to mimic the ABI-H0731 tablet; peginterferon alfa-2a
Intervention MeSH terms: Tenofovir; Peginterferon alfa-2a; Entecavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Safety of Nasal Influenza Immunisation in Egg Allergic Children
Condition: Egg Hypersensitivity
MeSH terms: Influenza, Human; Hypersensitivity; Egg Hypersensitivity
Study type: Observational

Summary: 
      Egg allergy is common in early childhood, affecting at least one in 50 preschool children.
      Influenza ("'flu") vaccines contain egg protein, as the vaccine is cultured in hen's eggs.
      There is robust data to support the safety of influenza vaccines (containing low or
      negligible amounts of egg protein) in patients with egg allergy.

      A new influenza vaccine, known as LAIV (Live Attenuated Intranasal Vaccine) has recently been
      approved by a number of licensing boards and is given by a spray into the nose. This new
      vaccine has been available in the United States for several years and is highly effective and
      against influenza infection, with an excellent safety profile in children without egg
      allergy. However, LAIV is also grown in hen's eggs and contains egg protein, and there are NO
      existing data on the safety of LAIV in egg-allergic children.

      The objective of this multicentre study is to assess the safety of intranasal LAIV in
      egg-allergic children, in order to demonstrate that these children can safely be given the
      new LAIV within a primary care health environment.
    


Intervention name(s): Administration of Live attenuated influenza vaccine
Intervention type(s): Biological
Other intervention name(s): Fluenz (EMA approval number EU/1/10/661/002); FluMist
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children and young people with egg allergy between 2-17 years old
      
Keywords: Egg allergy; Anaphylaxis; Children; Influenza vaccine
Different Retraining Methods vs Usual Care on the Prevention of Peritonitis in Peritoneal Dialysis
Condition: Peritonitis
MeSH terms: Peritonitis
Study type: Interventional

Summary: 
      To examine whether retraining via operation inspection or verbal education can reduce the
      risk for peritonitis in PD patients.
    

Detailed description: 
      The design is prospective, randomized, controlled study. At baseline (during the first
      month), they will receive a standard training program on performing bag exchange and
      education on the prevention of peritonitis.

      Then the participants will be randomized into three groups: retraining via operation
      inspection (G1), retraining via verbal education (G2) and usual care (G3). Retraining will be
      performed every 2 months in G1 and G2 group.

      During the following 2 years or a longer period, all the participants will be followed up
      frequently with outcome events recorded.
    

Intervention name(s): operation inspection
Intervention type(s): Behavioral
Intervention description(s): Retraining via operation inspection means that nurses check if patients can follow the taught skill during the procedure of bag exchange and correct wrong steps in one-to-one way every 2 months.
Retraining via verbal education means that nurses remind patients of key points of bag exchange through interactive quiz derived from above checklist every 2 months till 24 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: peritoneal dialysis; retraining; peritonitis
The Efficacy of Botulinum Toxin in Disabling Multiple Sclerosis (MS) Tremor
Condition: Multiple Sclerosis; Tremor
MeSH terms: Multiple Sclerosis; Tremor; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The incidence of tremor in Multiple Sclerosis (MS) has been estimated to affect up to 2/3rds
      of patients. Over half of the tremors involve the upper limb and frequently lead to further
      disability. Medical treatment of MS tremor is generally unrewarding, although carbamazepine,
      clonazepam, glutethimide, hyoscine, isoniazid, ondansetron, primidone, and
      tetrahydrocannabinol have been reported to have some beneficial effect but published evidence
      of effectiveness is very limited. The investigators' experience to date suggests that many of
      the upper limb tremors may potentially be responsive to Botulinum toxin injection therapy.

      Aims:

      1. The investigators aim to determine the efficacy of commonly used doses of BOTOX on the
      patients with symptomatic unilateral or bilateral arm tremor due to MS; and any side effects
      associated with this treatment.
    


Intervention name(s): Botulinum Toxin Type A
Intervention type(s): Drug
Intervention description(s): Intramuscular injection in affected limb up to 100 Units. Two doses (one placebo, one active) 3 months apart.
Other intervention name(s): Botox
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety, Tolerability and Pharmacokinetic Study of SC1011 in Healthy Subjects
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this clinical trial is to learn about the safety, tolerability and
      pharmacokinetic profiles of SC1011 in healthy conditions. The main questions it aims to
      answer are: Safety and tolerability profiles in healthy subjects and pharmacokinetic profiles
      in healthy subjects. Participants will complete the study including screening period, dosing
      period, and observation period. Investigators will compare the inhibitory activity of SC1011
      tablets with pirfenidone capsules against the same biomarkers(e.g. blood TNFα) to see if they
      are different between the two drugs.
    

Detailed description: 
      This is a single-center, open label study to evaluate the safety，tolerability and
      pharmacokinetics of multiple administration of Sufenidone (SC1011) tablets conducted in 2
      groups.

      Eight subjects were enrolled in the sulforaphane 300 mg group and each subject was
      administered once within half an hour after breakfast on day 1, twice daily on days 2-6 and
      once within half an hour after breakfast on day 7 .

      Eight subjects were enrolled in the sulforaphane 400 mg group and each subject was
      administered for 7 consecutive days, with dosing consisting of one dose within half an hour
      after breakfast on day 1, twice daily on days 2-6, and once within half an hour after
      breakfast on day 7.
    

Intervention name(s): SC1011; Placebo tablet
Intervention type(s): Drug; Drug
Intervention description(s): SC1011 tablet; SC1011-matching placebo tablet
Other intervention name(s): experimental drug group; Control Group
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases
Ketamine Versus Propofol as ICU Sedation
Condition: Ketamine; Propofol; Sedation; Mechanical Ventilation
Study type: Interventional
Phase: Phase 4

Summary: 
      this study is to assess the hemodynamic profile of ketamine compared with propofol in
      critically ill, mechanically ventilated adult Patients study will be carried out on 100
      mechanically ventilated patients who received one sedative agent propofol or ketamine The
      patients will be randomized into two equal groups to receive either ketamine or propofol
      Group 1 (Ketamine group): ketamine is initiated at 0.5 mg/kg/h and titrated by 0.25 mg/kg/h
      every 15 minutes to a maximum dosage of 4 mg/kg/h to achieve appropriate sedation. Group 2
      (Propofol group): Propofol is initiated at 0.3 to 0.6 mg /kg/hr. and titrated by 0.3 to 0.6
      mg/kg/h every 5 to 10 minutes up to a maximum dosage of 4.5 to 4.8 mg/kg/hr. to achieve
      appropriate sedation.
    


Intervention name(s): Ketamine; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): ketamine is initiated at 0.5 mg/kg/h and titrated by 0.25 mg/kg/h every 15 minutes to a maximum dosage of 4 mg/kg/h to achieve appropriate sedation.; Propofol is initiated at 0.3 to 0.6 mg /kg/hr. and titrated by 0.3 to 0.6 mg/kg/h every 5 to 10 minutes up to a maximum dosage of 4.5 to 4.8 mg/kg/hr. to achieve appropriate sedation.
Intervention MeSH terms: Ketamine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Adoptive Cellular Immunotherapy Following Autologous Peripheral Blood Stem Cell Transplantation for Multiple Myeloma
Condition: Myeloma; Transplant-eligible Patients
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether the administration of highly effective
      "killer" cells (cytotoxic T cells), along with Interleukin-2 (IL-2) and Recombinant Human
      Granulocyte Colony Stimulating Factor (GM-CSF) immediately following Autologous Peripheral
      Blood Stem Cell Transplantation (APBSCT) will enhance anti-tumor immune reconstitution and
      improve outcome of Multiple Myeloma patients.

      The overall hypothesis of this proposal is that immediately following APBSCT the immune
      reconstitution is optimal to administer "killer" cells, combined with the administration of
      IL-2 and GM-CSF.
    


Intervention name(s): Ex-vivo expanded effector cells
Intervention type(s): Biological
Intervention description(s): This trial will test if the combination of infusing ex vivo expanded cytotoxic effector cells with IL-2 and GM-CSF post-transplant will accelerate immune reconstitution, resulting in an effector cell-versus-myeloma effect and, possibly, improved clinical outcomes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PERsonal ContExtual Precision healTh
Condition: Hypertension; Depression
MeSH terms: Hypertension; Depression
Study type: Interventional

Summary: 
      The exponential growth of physiological, behavioral and environmental data generated through
      consumer mobile health (mHealth) devices and Internet of Things (IoT) technology provide
      unprecedented sources of personalized and contextual health information. If linked to
      clinical health data from the Electronic Health Record (EHR), these data can provide dynamic
      and individualized views of patient health states and trajectories that can greatly inform
      clinical care and health-related research. The investigators propose to advance precision
      health through the development and evaluation of a mobile application and data platform that
      collects, harmonizes and integrates mHealth and environmental data from patients' daily lives
      with their clinical histories and electronic health record data.

      The investigators propose a participatory design approach to implement and evaluate a
      precision health platform through the study and modeling of hypertension (HTN) and depression
      in patient communities of UC Davis (UCD) and UC San Francisco (UCSF). These chronic diseases
      have high prevalence across geography, socioeconomic status, and race/ethnicity, and have
      significant economic, societal and personal costs. They are considerably challenging to
      manage due to difficulties in acquiring high-quality and consistent data from patients
      outside of their clinical care appointments that is so needed for a full view of the
      patient's disease state. Despite a broad array of self-monitoring devices and consumer
      applications, mHealth data are not getting into the clinical care process, and patients do
      not regularly monitor their own health states, particularly during periods of medication
      change, when frequent assessments are especially important.

      The investigators propose to conduct a 6-month single arm feasibility study of 200 ambulatory
      men and women (100 each at UCSF and UCD) with either hypertension or depression to implement
      an open, web-accessible, standards driven and patient-centric data platform for the
      integration of patient-reported and clinical data.
    


Intervention name(s): Mobile Health Monitoring
Intervention type(s): Behavioral
Intervention description(s): Use of mobile health application to monitor blood pressure and mood.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Smartphone Addiction and Muscular Disorder
Condition: Myofascial Trigger Point
MeSH terms: Behavior, Addictive; Internet Addiction Disorder
Study type: Observational

Summary: 
      Background and aim: The use of smartphones, which has reached the level of addiction causes
      some physical and psychological health problems. The aim was to examine the musculoskeletal
      disorders of the neck and upper extremities of mobile phone addiction in a population of
      young adults.

      Methods: The study is a cross sectional research conducted on students of a university in
      İstanbul between December 2018-October 2020. The level of addiction was assessed with the
      Smartphone Addiction Scale Short Form (SAS-SF). The posture of participants was evaluated by
      New York Posture Rating Chart (NYPRC), mostly usage smartphone posture, forward head and
      myofascial trigger points were questioned according to Simon and Travel criteria.
      Mann-Whitney U test Pearson's chi-squared test were used for analyzing the data.
    


Intervention name(s): EVALUATION
Intervention type(s): Other
Intervention description(s): The level of addiction was assessed with the Smartphone Addiction Scale Short Form (SAS-SF). The posture of participants was evaluated by New York Posture Rating Chart (NYPRC), mostly usage smartphone posture, forward head and myofascial trigger points were questioned according to Simon and Travel criteria. Mann-Whitney U test Pearson's chi-squared test were used for analyzing the data.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The participants of this study included 136 healthy students between the ages of 18 - 25
        years. The study group consisted of 84 females and 52 males.
      
Keywords: Smartphone; mobile phone addiction; myofascial trigger point; forward head
Study to Compare the Efficacy of GSK Biologicals' Adjuvants in Combination With the Antigen of the Hepatitis B Vaccine
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this Observer-blind study is to compare different Adjuvant Systems with the same,
      well-known antigen (HBsAg) already used in the GSK marketed vaccines against Hepatitis B
      (Engerix-BTM and FendrixTM), in order to better understand the immune response induced by
      each of the Adjuvant System.

      This Protocol Posting has been updated following Protocol amendment 6, October 2009. The
      section impacted is Eligibility Criteria
    


Intervention name(s): Engerix-B™; Fendrix™; GSK Biologicals' Hepatitis B vaccines (GSK223192A); HBsAg (Booster injection)
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 2 doses intramuscular injections; 2 doses intramuscular injections; 2 doses intramuscular injections 3 different formulations of (GSK223192A), each administered to 1 group; Single dose intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Adjuvant Systems; Hepatitis B
Coupler-Based Hearing-Aid Fitting Approach for Experienced Users
Condition: Hearing Loss
MeSH terms: Hearing Loss; Deafness
Study type: Interventional

Summary: 
      The overall aim of the study is to compare the verification accuracy and hearing-aid outcomes
      between the traditional, fitting approach where the patient is present during the visit and a
      coupler-based fitting approach where the patient is not present and mailed their hearing
      aids. If the coupler-based fitting protocol tested in this study as effective as the
      traditional fitting protocol, then patients receiving replacement hearing aids may circumvent
      a face-to-face visit.
    

Detailed description: 
      This study will incorporate a verification technique that simulates the patient's actual ear
      during probe microphone verification measurements, called real-ear to coupler difference
      (RECD). Because the patient's ear is not used during the RECD measurement, but rather
      simulated, the patient would not need to be present during the RECD verification. This RECD
      hearing aid verification can occur in the clinic after which the hearing aids will be mailed
      to the patient. This study will compare the fitting accuracy and outcomes between the two
      approaches.
    

Intervention name(s): standard hearing aid fitting; coupler-based fitting; coupler-based fitting
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): standard hearing aid, face-to-face fitting; coupler-based fitting using average RECDs; coupler-based fitting using measured RECDs
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hearing loss; hearing aids; outcome assessment