bioihbjkbjnl/mcl2 huggingface dataset:
Study of Recombinant Human Serum Albumin/Interferon alpha2b Fusion Protein in Hepatitis B Patient
Condition: Hepatitis B Virus
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the dosages of recombinant human serum
      albumin/interferon alpha2b fusion protein injection on HBV subjects. The secondary purposes
      is to get the PK/PD data in recombinant human serum albumin/interferon alpha2b fusion protein
      injection on HBV subjects.
    

Detailed description: 
      This is an open-label study that will be conducted at three sites in China to characterize
      the PK/PD profile, safety and tolerability of Recombinant Human Serum Albumin/interferon
      alpha2b Fusion Protein in HBV subjects. Subjects will receive a single dose of Recombinant
      Human Serum Albumin/interferon alpha2b Fusion Protein or active comparator Pegasys at Day 0.
      A multipule-dose administration in HBV subjects will last 12 weeks after four weeks washout
      period.
    

Intervention name(s): Human Serum Albumin/interferon alpha2b fusion protein; Pegasys
Intervention type(s): Biological; Biological
Intervention description(s): In experiemental groups, each subject will recieve 600,750,900mg once per two weeks during multiple dose period.; In comparator group, each subject will recieve 180mcg once per week.
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study To Assess The Effect Of SB-705498 In A Capsaicin Challenge Model
Condition: Rhinitis
MeSH terms: Rhinitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to look at the affect of SB-705498 on rhinitis symptoms, as induced by
      capsaicin challenge
    


Intervention name(s): SB-705498; Placebo; Caspaicin
Intervention type(s): Drug; Drug; Other
Intervention description(s): Subjects will be administered a single dose of 400 mg SB-705498; Subjects will be administered SB-705498 matching placebo tablets; Subjects will be challenged with 0.5 µg, 5.0 µg and 50 µg intranasal dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Capsaicin challenge
Immunogenicity and Safety of GSK Biologicals' HPV Vaccine 580299 in Healthy Japanese Females 10-15 Years of Age
Condition: Infections, Papillomavirus
MeSH terms: Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      Human papillomavirus (HPV) infection has been established as a necessary cause of cervical
      cancer. GSK Biologicals has developed an HPV vaccine (580299) which targets the 2 most common
      oncogenic HPV types (HPV-16 and HPV-18), found in approximately 70% of all cervical cancers.
      In previous trials, the vaccine has been found to be efficacious in the prevention of
      incident and persistent HPV-16/18 infections and associated cytological abnormalities. HPV
      vaccination should ideally be performed before onset of sexual activity. Previous studies
      showed that GSK Biologicals' HPV vaccine 580299 is safe and immunogenic when administered to
      European, Asian, Latin American and Australian pre-adolescents and adolescents. Here, we aim
      to assess the immunogenicity and safety of the GSK Biologicals' HPV vaccine 580299 in healthy
      Japanese pre-adolescent and adolescent female subjects aged 10-15 years. The Protocol Posting
      has been updated in order to comply with the FDA Amendment Act, Sep 2007.
    


Intervention name(s): Cervarix™ (HPV-16/18 L1 VLP AS04)
Intervention type(s): Biological
Intervention description(s): Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
Other intervention name(s): GSK Biologicals' HPV-16/18 VLP/AS04 vaccine
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Human Papillomavirus (HPV) vaccine; safety; cervical cancer; immunogenicity; vaccine; viral infections; pre-adolescent and adolescent females
Relative Bioavailability Study in Healthy Male Subjects for ZD4054 (Zibotentan) Immediate Release Tablets.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to see how different formulations of ZD4054 (Zibotentan) are absorbed
      by the body. As for all clinical trials, safety and tolerability of the drug will be
      evaluated.
    


Intervention name(s): ZD4054; ZD4054; ZD4054; ZD4054
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Treatment period 1: 10mg oral solution; Treatment period 2: 3 of the 5 tablet variations (A-E) to be taken in a random sequence, but not the same tablet twice.; Treatment period 3: 3 of the 5 tablet variations (A-E) to be taken in a random sequence, but not the same tablet twice.; Treatment period 4: 3 of the 5 tablet variations (A-E) to be taken in a random sequence, but not the same tablet twice.
Other intervention name(s): Zibotentan; Zibotentan; Zibotentan; Zibotentan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Healthy Volunteers; ZD4054
Pleural Manometry in Thoracocentesis
Condition: Thoracocentesis of Pleural Effusion
MeSH terms: Pleural Effusion
Study type: Interventional

Summary: 
      The study aiming to measure the pleural pressure during thoracocentesis in patients with
      pleural effusion and the value of their measurement in both diagnostic and therapeutic
      decisions.
    

Detailed description: 
      This prospective controlled trial study will be performed between July 2019 and December
      2020. the investigators will enroll patients with large volume pleural effusion referred to
      our Cardiothoracic Department, Faculty of Medicine, Ain Shams University to perform
      therapeutic thoracentesis. All the patients will sign an informed consent for pleural
      pressure monitoring during and after therapeutic thoracentesis.

      The study aiming to measure the pleural pressure during thoracocentesis in patients with
      pleural effusion and the value of their measurement in both diagnostic and therapeutic
      decisions.
    

Intervention name(s): Pleural Manometry
Intervention type(s): Diagnostic Test
Intervention description(s): Recording pleural pressure during therapeutic thoracocentesis using a simple water manometer.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This prospective controlled trial study will be performed between August 2019 and August 2020. We will enroll patients with large volume pleural effusion referred to our Cardiothoracic Department, Faculty of Medicine, Ain Shams University to perform therapeutic thoracentesis. All the patients will sign an informed consent for pleural pressure monitoring during and after therapeutic thoracentesis.
Masking: None (Open Label)
Primary purpose: Diagnostic
Pediatrics Testotoxicosis Study [Bicalutamide Anastrozole Treatment for Testotoxicosis]
Condition: Puberty, Precocious
MeSH terms: Puberty, Precocious
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to investigate whether bicalutamide given in
      combination with anastrozole once daily for 12 months is effective in treating testotoxicosis
      in boys. Testotoxicosis is a condition that causes early puberty in boys including growth in
      height, and development of muscles and sexual organs .
    


Intervention name(s): Bicalutamide; Anastrozole
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): Casodex; Arimidex; ZD1033
Intervention MeSH terms: Anastrozole; Bicalutamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Testotoxicosis; Familial Male-limited Precocious Puberty (FMPP)
The Effectiveness of a Recovery Program for People With Mental Illness.
Condition: Mental Illness
MeSH terms: Mental Disorders
Study type: Interventional

Summary: 
      Recovery-oriented approach has been the main trend in mental health field. However, few
      recovery-oriented programs are available in Taiwan, and many Taiwanese people with mental
      illness don't understand the concepts of recovery. A program which provides recovery
      knowledge and assists in setting recovery goals is beneficial for Taiwanese people with
      mental illness. Hence, this study aimed to investigate the effectiveness of a recovery
      program for people with mental illness.
    

Detailed description: 
      This is a randomized control trial. Participants will be recruited from the psychiatric
      rehabilitation organizations in Taiwan. They will be randomly assigned to the intervention
      group or control group. The recovery program has 2 phases and consists of 20 classes, 1.5
      hour per class and one class per week. We will introduce concepts of recovery and personal
      strengths in phase 1. Then, we will help participants to set goals and implement their plans
      in phase 2. Participants will fill out five questionnaires during the recruitment meeting,
      including Stages of Recovery Scale, Medical Outcomes Study Social Support Survey, The Hope
      Scale, Rosenberg Self-Esteem Scale and Brief Symptom Rating Scale-50. They will fill out the
      same questionnaires plus the course satisfaction survey in the end of phase 1 and 2. Six
      months later, participants will receive a follow-up interview and fill out the questionnaires
      again. The control group will receive a spiritual book and complete the questionnaires at the
      same time as the intervention group.
    

Intervention name(s): Recovery group
Intervention type(s): Behavioral
Intervention description(s): The researchers designed a recovery group suited to Taiwanese with mental illness, according to content of the Pathways to Recovery (PTR): A Strengths Recovery Self-Help Workbook (Ridgway et al., 2002) and recovery-related literature (Davidson et al., 2005; Ridgway, 2001)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Intestinal Permeability in Children/Adolescents With Functional Dyspepsia
Condition: Functional Dyspepsia
MeSH terms: Dyspepsia
Study type: Observational

Summary: 
      The main purpose of this study is to evaluate whether intestinal permeability and/or serum
      zonulin concentration is increased in children/adolescents with functional dyspepsia (FD).
      The study will also explore the relationships between intestinal permeability, mucosal
      inflammation and anxiety in FD patients.
    

Detailed description: 
      Recurrent abdominal pain is a common complaint among school-age children, being present in up
      to 15% at any given time. It represents the most common chronic pain entity in pediatric
      patients. The great majority of these patients will have a functional gastrointestinal
      disorder (FGID). The most common FGID in these patients is functional dyspepsia (FD), defined
      as upper abdominal pain or discomfort unrelieved by bowel movement and in the absence of a
      structural or biochemical explanation for the pain. The etiology of FD is multifactorial,
      including biological factors, and these factors can be viewed within a biopsychosocial model.
      Biological factors include inflammation, dysmotility and increased visceral sensitivity.
      These biological factors are influenced by and are interactive with psychosocial factors such
      as anxiety, depression and social interaction. This study will evaluate intestinal
      permeability as a measure of barrier dysfunction and investigate the correlations between
      increased permeability, mucosal inflammation and anxiety scores to provide further insight
      into the etiology of FD, thereby assisting in the development and selection of treatment
      modalities.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children with chronic abdominal pain.
      
Keywords: dyspepsia; gastrointestinal disease; indigestion
Safety and Efficacy of L19TNF in Patients With Isocitrate Dehydrogenase (IDH) Wildtype WHO Grade III / IV Glioma at First Relapse
Condition: Glioma of Brain
MeSH terms: Glioma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Open label, non-randomized, mono-center Phase I/II study in subjects with IDH-wildtype WHO
      grade III / IV glioma at first relapse.
    

Detailed description: 
      The purpose of this study is to explore the safety and efficacy profile of the
      antibody-cytokine fusion protein L19TNF in patients with isocitrate dehydrogenase (IDH)
      wildtype WHO grade III / IV glioma at first relapse

      Phase I:

      The primary objective of this phase is to evaluate the safety of L19TNF in patients with
      IDH-wildtype WHO grade III / IV glioma at first relapse and to establish and confirm the
      recommended dose (RD) for phase II.

      Phase II:

      The primary objective of this phase is to evaluate antitumor activity of L19TNF in patients
      with IDH-wildtype WHO grade III / IV glioma at first relapse.
    

Intervention name(s): L19TNF
Intervention type(s): Drug
Intervention description(s): Patients will be assigned to the following increasing dose levels of L19TNF: 10 and 13 μg/kg.
Other intervention name(s): onfekafusp alpha
Intervention model: Single Group Assignment
Intervention model description: Open label, non-randomized, mono-center Phase I/II study in subjects with IDH-wildtype WHO grade III / IV glioma at first relapse.
Masking: None (Open Label)
Primary purpose: Treatment
A Study in Healthy Volunteers to Investigate How Much Test Medicine [14C]-Uproleselan is Taken up by the Body When Administered Directly Into the Vein (IV)
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to measure how the radiolabelled test medicine [14C]-Uproleselan
      (GMI-1271) is taken up, broken down and removed from the body when given intravenously (into
      a vein) in a group of 6 males. 'Radiolabelled' means that the test medicine has a radioactive
      component which helps us to track where the drug is in the body. Blood urine and fecal
      samples will be collected at specific times throughout the study to measure amounts of the
      test medicine in the body.
    


Intervention name(s): Uproleselan
Intervention type(s): Drug
Intervention description(s): [14C]-Uproleselan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Nutritional Status in Orthognathic Surgery Patients
Condition: Malocclusion
MeSH terms: Malocclusion
Study type: Observational

Summary: 
      The aim of this study is to determine the effect of orthognathic surgery on nutritional
      status, anthropometric measurements, food consumption levels, physical activity levels,
      biochemical parameters, chewing ability and oral-health impact profile.
    

Detailed description: 
      Sub-objectives of the study;

        -  Determining nutritional status changes after orthognathic surgery

        -  Determining changes in anthropometric measurements (body weight, BMI, fat mass, muscle
           mass, total body water, waist circumference, hip circumference, mid-upper arm
           circumference) after orthognathic surgery

        -  Determining food consumption changes after orthognathic surgery

        -  Determining changes is physical activity levels after orthognathic surgery

        -  Determining changes in biochemical parameters 3 months after orthognathic surgery

        -  Determining changes in chewing ability after orthognathic surgery

        -  Determining changes in oral-health impact profile after orthognathic surgery

        -  Determining changes in pain intensity

      The aim of this study is to compare these parameters preoperative to postoperative timeline
      of orthognathic surgery patients.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who applied to the Marmara University Faculty of Dentistry Department of Oral and
        Maxillofacial Surgery who applied for dentomaxillofacial deformities and needed
        orthognathic surgery will be included in the study. It is aimed to invite all patients who
        applied to the clinic to the research.
      
Keywords: Orthognathic surgery; Malocclusion; Nutritional Status
A Study to Assess Safety and Tolerability of ASP1941 After Single and Repeated Administration in Healthy Subjects
Condition: Healthy Volunteer; Pharmacokinetics of ASP1941
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of
      ASP1941 in healthy adult male subjects.
    

Detailed description: 
      This study consists of two parts. In part-1, a single oral dose of ASP1941 or placebo is
      administered to healthy adult male subjects to investigate the safety, tolerability,
      pharmacokinetics and pharmacodynamics in healthy adult males. In part-2, ASP1941 or placebo
      are is administered by a multiple dose regimen.
    

Intervention name(s): ASP1941; placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Intervention MeSH terms: Ipragliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: Food effect
Broccoli Sprout Dose Response: Bioavailability and Effects of Air Pollutants
Condition: Environmental Carcinogenesis
MeSH terms: Carcinogenesis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will examine the extent to which lower doses of a broccoli-derived beverage
      enhance the detoxication of air pollutants excreted in urine as compared to an maximal dose
      shown to be effective previously.
    

Detailed description: 
      This is a 10-day placebo control Phase II broccoli sprout intervention to be conducted in
      Qidong, P.R. China. Up to twelve hundred people from the farming townships will be screened
      and one hundred seventy eligible individuals will be enrolled in the study. Participants will
      be randomized into 4 treatment groups: one will receive a juice beverage containing a
      standard dose of glucoraphanin- and sulforaphane-rich broccoli sprout powder mixed in
      pineapple juice, lime juice and water, the second will receive one-half dose, the third
      one-fifth dose and the fourth group will receive placebo beverage containing pineapple juice,
      lime juice and water. Participants will drink their assigned beverage every evening and
      provide consecutive 12-hour urine collections throughout the duration of the study.
    

Intervention name(s): Broccoli Sprout-derived Beverage; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebos.; Placebo as comparison to broccoli sprout-derived beverages
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Fish Oil Study for High Triglyceride Levels in Children
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      High triglyceride levels are increasingly recognized in children, particularly those who are
      overweight. There are no studies of treatment of high triglycerides in children and
      adolescents. Fish oil is attractive because it is considered safe and effective for treating
      high triglycerides in adults and has been used safely for other purposes in children. The
      investigators will conduct a randomized study of Lovaza (the only prescription omega-3 fish
      oil medication) in 44 children and adolescents to study efficacy in lowering triglycerides,
      safety, and possible mechanisms of beneficial effects.
    

Detailed description: 
      Participants (n = 42, age 14 + 2 yrs) with hypertriglyceridemia and LDL cholesterol < 160
      mg/dl were enrolled in a randomized double blind cross over trial comparing 4 g fish oil
      daily with placebo. Treatment interval was 8 weeks with a 4 week wash out, between the two
      treatment intervals. Lipid profile, lipoprotein particle distribution and size, glucose,
      insulin, high sensitivity C reactive protien (CRP), interleukin-6, fibrinogen, plasminogen
      activator inhibitor-1 (PAI-1), and thrombin generation were measured.

      Patients were evaluated at 6 time points: Visit 1/baseline (week 0), Visit 2/randomization
      (week 4), Visit 3/after treatment 1 (week 12) , Visit 4/after wash out (week 16), Visit
      5/after treatment 2 (week 24) and Visit 6/close out (week 28) . Patients were advised to
      maintain a stable diet and not alter baseline fish consumption . One participant took an oral
      contraceptive throughout the trial. Any fish oil supplements were discontinued. Advice on a
      heart healthy diet was provided. Blood pressure (right arm sitting with appropriate sized
      cuff, taken 3 times, last measurement used), height, and weight were measured at the
      beginning of the study, after the first wash out period, and close out. Participant phone
      contact was made during each treatment arm to assess diet stability. Fasting lipid profile
      was performed at every visit. Red blood cell fatty acid profile and secondary endpoints were
      performed at all visits except baseline.
    

Intervention name(s): Omega-3-acid ethyl esters; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Omega-3-acid ethyl esters (Lovaza), two 1-gram capsules taken twice daily for 8 weeks; Placebo (corn oil), two 1-gram capsules taken twice daily for 8 weeks
Other intervention name(s): Lovaza; Corn Oil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment