bioihbjkbjnl/mcl2 huggingface dataset:
Partially Blind Study to Evaluate Immunogenicity & Safety of GSK Bio's HPV Vaccine 580299 in Healthy Women Aged 9-25 Yrs
Condition: Infections, Papillomavirus
MeSH terms: Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Human Papillomavirus (HPV) infection has been established as a necessary cause of cervical
      cancer. GlaxoSmithKline (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 this vaccine has been found to be efficacious in the
      prevention of incident and persistent HPV-16/18 infections and associated cytological
      abnormalities and cervical dysplasia. In this partially-blind study, GSK Biologicals will
      evaluate the safety and immunogenicity of the HPV vaccine using an alternative schedule and
      an alternative dosing when administered in healthy young females aged 9 to 25 years, as
      compared to the standard HPV vaccine. The Protocol Posting has been updated in order to
      comply with the FDA Amendment Act, Sep 2007. The protocol posting has been updated following
      a protocol amendment.
    


Intervention name(s): Cervarix; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Intramuscular injection, different dosing /schedule; Intramuscular injection, different dosing /schedule
Other intervention name(s): GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) vaccine 580299
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: viral infections; Human Papillomavirus (HPV) vaccine; safety; vaccine; immunogenicity; cervical cancer
Effect of Squat Training on Body Composition, Muscular Strength and Motor Fitness for Youth- Randamized Trial
Condition: Physical Conditioning
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effects of body mass-based squat training on
      body composition, muscular strength and motor fitness in adolescents.
    

Detailed description: 
      Body composition Percent body fat by bioimpedance muscle thickness at the thigh anterior by
      ultrasound

      Muscle strength Maximal voluntary knee extension torque by myometer

      Motor fitness sprint velocity by non-motorized treadmill Jump height by a matswitch system.
    

Intervention name(s): squat exercise training
Intervention type(s): Other
Intervention description(s): Intervention may include squat exercise for 8 weeks
Other intervention name(s): school-based exercise training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: squat exercise
Minimally Invasive Interval Debulking Surgery in Ovarian Neoplasm: a Feasibility Study
Condition: Stage IV Ovarian Carcinoma; Effects of Chemotherapy; Peritoneal Cavity Cancer
MeSH terms: Neoplasms; Ovarian Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase II multicentric study
    

Detailed description: 
      The aim of this prospective Phase II multicentric study is to assess feasibility and early
      complications rate of "total laparoscopic/robotic" interval debulking surgery in patients
      with a clinical complete/partial response to neoadjuvant chemotherapy for advanced ovarian
      cancer.
    

Intervention name(s): Laparoscopic interval debulking surgery
Intervention type(s): Procedure
Intervention description(s): Diagnostic laparoscopy with a careful exploration of peritoneal cavity: if available a 5 mm "flexible tip" videolaparoscope will be used to explore all peritoneal recesses.For eligible patients,will be placed 3 5mm trocar in standard position for pelvic surgery:cytoreduction will consist in total/radical hysterectomy,bilateral salpingo-oophorectomy,radical omentectomy.If needed pelvic/upper peritonectomy will be performed:in these cases additional trocar can be placed in right or left subcostal spaces. All surgical procedure requested will have be carried out by laparoscopy/robotic or by laparotomy,in case of increased surgical risk or technical impossibility:the case will be registered as laparotomic conversion.At the end of surgical procedures residual tumor will be registered
Other intervention name(s): Laparoscopy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ovarian Cancer; Laparoscopy; Neoadjuvant Chemotherapy; Robotic; Interval Debulking Surgery
Laser for Oral Mucositis in Pediatric Onco-hematology
Condition: Stomatitis
MeSH terms: Mucositis; Stomatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Children with cancer undergoing intensive chemotherapy (CT) regimens experience many side
      effects among which oral mucositis (OM) is one of the most debilitating. Modifications of
      CT's schedule and prolonged hospitalization may be necessary in presence of OM, causing poor
      general conditions and debilitation. Moreover, the use of narcotic analgesics and total
      parenteral nutrition may be required, triggering not only a physical deficit but also an
      economic burden. Despite the frequency and impact of OM among children with cancer, there is
      no consensus on standard therapy for this condition. Previous studies demonstrated that high
      power laser therapy can help the maintenance of nutritional status in patients with OM and
      can remarkably reduce costs/resources needed. Laser therapy has evidence of efficacy in
      reducing symptoms and in preventing the onset of OM in adult cancer patients but only one
      randomized controlled trial, with a limited number of children enrolled, supports its use in
      children for treatment of OM induced by chemotherapy.

      This multicenter double-blind randomized controlled trial evaluates the efficacy of laser for
      treatment of oral mucositis secondary to chemotherapy in children aged 3-17 years.

      The study involves 8 italian hospitals.
    


Intervention name(s): Laser therapy; Sham therapy
Intervention type(s): Device; Device
Intervention description(s): Treatment with K-Laser Cube3 during 4 consecutive days, with the following protocol: 660-970 nm wavelength, 3,2W mean power (6.4W pulsating at 50%), 3'51'' duration, 1-20000 Hz frequency, and 1 cm2 spot size. Laser application was performed all over the oral cavity.; Only the laser pointer movement, without laser activation, during 4 consecutive days, all over the oral cavity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stomatitis; Laser; Children; Chemotherapy; Treatment
Comparison of 18F-fluorodeoxyglucose Positron Emission Tomography and Coronary Computed Tomography in Assessing Vascular Inflammation
Condition: Atherosclerosis
MeSH terms: Atherosclerosis; Inflammation
Study type: Observational

Summary: 
      Vascular inflammation is a key factor in both the pathogenesis and outcome of
      atherosclerosis. 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a
      promising tool for identifying and quantifying vascular inflammation within atherosclerotic
      plaques.cardiac multidetector-row CT can provide measurements of coronary artery calcium
      (CAC), the degree of stenosis, and the characteristics of plaque including its potential
      vulnerability. Therefore, the purpose of the investigators study is to compare the usefulness
      of 18 FDG-PET and MDCT in assessing the vascular inflammatory status and vulnerability.
    


Intervention name(s): Cross section study
Intervention type(s): Other
Intervention description(s): This is not intervention study. The purpose of the study is to examine the relationship of vascular inflammation assessed by 18FDG-PET and MDCT at the cross section setting
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy participants who underwent a medical health check in the health promotion center in
        Korea Guro University
      
Biospecimen description: 
      plasam and serum
    
Keywords: atherosclerosis; vascular inflammation; MDCT; 18FDG-PET
SMS Reminders for Exercise Among Older Adults. Malaysian Physical Activity for Health Study
Condition: Physical Activity; Exercise
Study type: Interventional

Summary: 
      The purpose of the study is:

      1) To evaluate the efficacy and feasibility of an SMS reminder intervention for promoting an
      health-related exercise programme (myPAtHS) among older Malaysian adults, in a randomized
      controlled trial (RCT).

      Hypothesis: Frequency and duration of the exercise programme execution will be higher for the
      SMS reminder condition compared to the programme only condition. The effect may be reduced
      from post- to follow-up measurement (24 weeks after baseline and 12 weeks after
      post-measurement) but all outcomes will remain significantly higher at 24 weeks.
    


Intervention name(s): Exercise programme plus SMS reminders
Intervention type(s): Behavioral
Intervention description(s): Participants will receive SMS reminders for their myPAtHS exercise programme compared to the other group where participants will only receive the myPAtHS exercise programme.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: health; older adults; mobile phone
Study of the Effects of Itraconazole and Rifampin on LOXO-305 in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to learn about how itraconazole and rifampin affect
      LOXO-305 in healthy participants. Participation could last about 8 weeks.
    


Intervention name(s): LOXO-305; Itraconazole; Rifampin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral LOXO-305; Oral itraconazole; Oral rifampin
Intervention MeSH terms: Itraconazole; Rifampin; Pirtobrutinib
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Evaluate the Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of HLX71 (Recombinant Human Angiotensin-converting Enzyme 2-Fc Fusion Protein for COVID-19) in Healthy Adult Subjects
Condition: COVID 19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Phase I Clinical Study to
      Evaluate the Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of
      HLX71 in Healthy Adult Subjects
    

Detailed description: 
      A randomized, double-blind, single-dose by intravenous administration, placebo-controlled,
      dose escalation, first-in-human study is proposed to evaluate the safety, tolerability,
      pharmacodynamics, pharmacokinetics and immunogenicity of HLX71 in healthy subjects.
      Investigators plan to enroll 10 subjects in each of the 4 dose cohorts at 2.5 mg/kg, 5 mg/
      kg, 10 mg/kg and 15 mg/kg, of which 2 receive intravenous injections of placebo and 8 receive
      intravenous injections of the investigational product (IP). A total of 40 subjects will be
      enrolled.
    

Intervention name(s): HLX71; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Single-dose, intravenous infusion; Single-dose, intravenous infusion
Other intervention name(s): Recombinant Human Angiotensin-Converting Enzyme 2-Fc Fusion Protein
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: The investigators plan to enroll 8 subjects in each sequence, of which 2 receive intravenous injection of placebo and 6 receive intravenous injection of IP. Subjects are allocated in two groups randomly.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Seasonal Intermittent Preventive Treatment With Sulfadoxine-Pyrimethamine in Children in Mali
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional

Summary: 
      Recent, randomized controlled trials conducted in areas of perennial malaria transmission
      have shown that intermittent preventive treatment (IPT) given at the time of vaccination
      reduced the incidence of the first episode of malaria and severe anaemia during the first
      year of life by more than 50% without there being any rebound in the subsequent year.
      However, in countries such as Mali, where malaria is highly seasonal and prevalent in older
      children, IPT in infants may not be the optimum way in which to use antimalarial drugs to
      prevent malaria. An alternative approach is to give intermittent preventive treatment to
      children at risk just during the rainy season. Here we propose (i) to evaluate the impact of
      two seasonal IPT (sIPT) with Sulfadoxine-pyrimethamine (SP) given at 8 weeks interval on the
      incidence of malaria disease in children of 6 months to 10 years in an area of seasonal
      transmission, in Kambila, Mali; (ii) to assess the impact of this strategy on the in vivo
      response of P. falciparum to SP; (iii) to assess the potential rebound effect of this
      strategy on the subsequent transmission season after the cessation. Children 6 months-10
      years in Kambila, Mali will randomized to receive either IPT with SP twice at 8 weeks
      interval or no IPT during the transmission season and will followed up for 12 months.
      Subjects will be also followed during the subsequent transmission season to assess possible
      rebound effect. Clinical malaria cases will be treated with SP and followed for 28 days to
      assess the in vivo response during both periods.
    


Intervention name(s): Seasonal IPT in children - Sulfadoxine-pyrimethamine
Intervention type(s): Drug
Intervention description(s): Subjecs randomized to receive two intermittent preventive treatments with standard recommended treatment doses of Sulfadoxine-pyrimethamine at 8 weeks interval during the peak malaria transmission season.
Intervention MeSH terms: Pyrimethamine; Sulfadoxine; Fanasil, pyrimethamine drug combination
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: malaria; intermittent preventive treatment; season; children
Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women
Condition: Contraception
Study type: Interventional

Summary: 
      Because of misoprostol's known ability to cause cervical dilation, some family planning
      providers give their patients a dose of this drug prior to insertion. The goal of this study
      is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases
      insertion and decreases pain.
    

Detailed description: 
      There are currently 2 intrauterine devices (IUDs) available in the U.S., the copper T380
      (paragard) and levonorgestrel IUD (Mirena). The effectiveness of IUDs is very similar to
      tubal sterilization[1], with an overall unintended pregnancy rate of less than 1% in the
      first year, and lower failure rates in subsequent years. The cervix of a nulliparous woman
      has a smaller diameter and can lead to more difficult and uncomfortable IUD insertions.
      Because of misoprostol's known ability to cause cervical dilation, some family planning
      providers give their patients a dose of this drug prior to insertion. The goal of this study
      is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases
      insertion and decreases pain. The null hypothesis is that misoprostol does not influence
      difficulty of insertion or patient perception of pain. The primary outcome is the ability to
      insert the IUD without dilation of the cervix or using ultrasound for guidance.
    

Intervention name(s): Misoprostol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 400mcg of misoprostol taken buccally 2 hours prior to IUD insertion visit; Pill that is identical to the study drug in appearance, taste and smell, taken buccally 2 hours prior to IUD insertion visit
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: IUD insertion; nulliparous women; contraception; family planning; IUD insertion in nulliparous women
Interaction of BI 425809 With Midazolam, Warfarin, Omeprazole and Digoxin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the influence of multiple doses of BI 425809 on single dose pharmacokinetics of
      midazolam (CYP3A4 probe drug), warfarin (CYP2C9 probe drug), omeprazole (CYP2C19 probe drug)
      and digoxin (P-gp probe drug)
    


Intervention name(s): Midazolam; Warfarin; Omeprazole; Midazolam; Digoxin; BI 425809
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Digoxin; Midazolam; BI 425809; Omeprazole; Warfarin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assess the Safety and Effectiveness of PROVIGIL Treatment in Children and Adolescents With Excessive Sleepiness
Condition: Narcolepsy
MeSH terms: Narcolepsy; Sleepiness
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to evaluate the safety and tolerability of treatment
      with PROVIGIL in children and adolescents with excessive sleepiness (ES) associated with
      narcolepsy or obstructive sleep apnea/hypopnea syndrome (OSAHS), when administered for up to
      6 months.
    


Intervention name(s): Modafinil
Intervention type(s): Drug
Intervention description(s): maximum dosage 400 mg/day (4 tablets)
Other intervention name(s): Provigil
Intervention MeSH terms: Modafinil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Safety and Efficacy of CAT-354
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel-arm study to
      evaluate the efficacy and safety of 3 subcutaneous (SC) treatment regimens of CAT-354 in
      adult subjects with uncontrolled, moderate-to-severe, persistent asthma.
    

Detailed description: 
      Study MI-CP199, a Phase 2a, randomized, double-blind, placebo-controlled, parallel-arm,
      multicenter study will evaluate the effect of 3 SC treatment regimens of CAT-354 on asthma
      control in adults with uncontrolled, moderate-to-severe, persistent asthma.
    

Intervention name(s): Placebo; CAT-354 150 mg; CAT-354 300 mg; CAT-354 600 mg
Intervention type(s): Other; Biological; Biological; Biological
Intervention description(s): Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.; CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.; CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.; CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
Other intervention name(s): Tralokinumab; Tralokinumab; Tralokinumab
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: CAT-354; Tralokinumab; Asthma
Food-specific IgG4-guided Elimination Diets Improve Allergy Symptoms in Children
Condition: Rhinitis, Allergic; Asthma, Allergic; Conjunctivitis, Allergic; Atopic Dermatitis; Chronic Urticaria
MeSH terms: Rhinitis; Rhinitis, Allergic; Conjunctivitis; Conjunctivitis, Allergic; Dermatitis; Urticaria; Chronic Urticaria
Study type: Observational

Summary: 
      Allergic diseases in children are major public health concerns due to their widespread and
      rising prevalence. The most classic pathway to trigger allergy is type I allergy mediated by
      immunoglobulin E(IgE), but the role of immunoglobulin G4(IgG4) in allergic diseases is still
      worth exploring.we have collected the data of allergic patients aged 0-14 years for
      retrospective cross-sectional analysis to evaluate the positive rates of total IgE, HDM IgE,
      FS-IgE and FS-IgG4. Meanwhile, investigators screened out patients who were treated with
      FS-IgG4-guided elimination diets with/without probiotics for more than 3 months to clarify
      the role of FS-IgG4 in childhood allergic diseases by assessing the improvement of clinical
      symptoms before and after treatment.
    

Detailed description: 
      Allergic diseases in children are major public health concerns due to their widespread and
      rising prevalence. And management of allergic diseases beyond medication, such as food
      management is also very important. The most classic pathway to trigger allergy is type I
      allergy mediated by immunoglobulin E(IgE), but the role of immunoglobulin G4(IgG4) in
      allergic diseases is still worth exploring.In present study, investigators have collected the
      data of allergic patients aged 0-14 years for retrospective cross-sectional analysis to
      evaluate the positive rates of total IgE, house dust mite (HDM) IgE, FS-IgE and FS-IgG4.
      Meanwhile, investigators screened out patients who were treated with FS-IgG4-guided diet
      elimination with/without probiotics for more than 3 months to clarify the role of FS-IgG4 in
      childhood allergic diseases by assessing the improvement of clinical symptoms before and
      after treatment. This retrospective study was conducted to clarify the clinical relevance of
      food-specific IgG4 in allergic diseases and the effect of dietary avoidance on clinical
      symptoms, thus making a breakthrough in the diagnosis and treatment of childhood allergies.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 407 patients were recruited. Of the all patients,141 were assigned to the
        respiratory system group, 124 to the skin system group and 142 to the multiple system
        group. The follow-up interval of patients in both groups before and after treatment was
        more than 3 months, with the longest follow-up interval being two and a half years.
      
Keywords: Immunoglobulin E; Immunoglobulin G; Elimination Diets; chlid