bioihbjkbjnl/mcl2 huggingface dataset:
Dose-Ranging Study of Quadrivalent Human Papillomavirus (HPV) (Types 6,11,16,18) L1 Virus-Like Particle (VLP) Vaccine (V501-007)(COMPLETED)
Condition: Papillomavirus Infections; Genital Diseases, Female
MeSH terms: Papillomavirus Infections; Genital Diseases; Genital Diseases, Female
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was conducted in 2 parts. Part A was a randomized, double-blind,
      placebo-controlled, multicenter, sequential dose-escalating evaluation. Part B was a
      randomized, double-blind (operating under in-house blinding procedures), placebo-controlled,
      multicenter, dose-ranging study.
    


Intervention name(s): Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20; Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40; Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80; Placebo (mcg) (Aluminum Adjuvant)225; Placebo (mcg) (Aluminum Adjuvant) 450
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): 20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.; 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.; 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.; placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.; placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.
Other intervention name(s): V501; V501; V501
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: HPV 6/11/16/18 infection and related genital disease
A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the relative biological availability and the effect of
      food on the drug levels of Danicamtiv in health adults.
    


Intervention name(s): Danicamtiv
Intervention type(s): Drug
Intervention description(s): Specified dose on specified days.
Other intervention name(s): BMS-986434; MYK-491
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BMS-986434; MYK-491; Healthy; Biological Availability; Food Effect
Glycaemic and Insulinaemic Responses After Consumption of FOS.
Condition: Glycaemia
Study type: Interventional

Summary: 
      The study aims to evaluate the glycaemic and insulinaemic response of short-chain
      fructo-oligosaccharides (scFOS) used to replace sugars (e.g. dextrose) in foods.
    


Intervention name(s): Sugar; FOS
Intervention type(s): Other; Other
Intervention description(s): A 210g chocolate dairy dessert made with 35g of dextrose.; A 210g chocolate dairy dessert made with 24g of dextrose and 11.2g of FOS.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Fructo-oligosaccharides; Sugar-reduced foods; Postprandial glucose response
Postoperative Pain After Dental Post Application
Condition: Postoperative Pain; Endodontically Treated Teeth; Vibration; Exposure
MeSH terms: Tooth, Nonvital; Pain, Postoperative
Study type: Interventional

Summary: 
      In this study the effect of dental post application on postoperative dental pain in patients
      with asymptomatic teeth after a single-appointment root canal treatment will be evaluated.
    

Detailed description: 
      The aim of this clinical study is to evaluate the effect of dental post application on
      postoperative pain intensity level in patients with asymptomatic teeth after a
      single-appointment root canal treatment. A total of one hundred patients with asymptomatic
      teeth and with no contradictory medical history who are indicated for non-surgical root canal
      treatment and application of a dental post at the Endodontic Clinic, Faculty of Dentistry,
      Istanbul Medipol University, between April and December of 2019 will be included. All of the
      patients will be recruited from the Istanbul Medipol University Dental Clinics in Istanbul.
      the patients will be divided in two groups (n=50). Consent will be obtained from all study
      participants before the treatment. After the root canal treatments are completed in
      single-visit, in the first groups dental posts will be applied immediately at the same visit
      and patients will be appointed for pain assessment. In group 2 after the root canal treatment
      a temporary filling be applied in the access cavity and patients will be appointed for pain
      assessment. Dental posts will be applied after the pain assessment is completed at the end of
      1 week. All treatments will be performed by one endodontist. Postoperative pain intensity
      will be assessed at 24, 48, and 72 h; 7 days; after the treatment. The teeth will be examined
      according to postoperative pain intensity levels,
    

Intervention name(s): Group 1: single-visit RCT; Group 2: two-visit RCT
Intervention type(s): Procedure; Procedure
Intervention description(s): both root canal treatment and post and core restoration of the coronal part of the tooth is completed in single visit prior to postoperative pain evaluation at 24, 48 and 72-h and 7-day follow-up time; after root canal treatment is completed, postoperative pain evaluation will be conducted in this group at 24, 48 and 72-h and 7-day follow-up time. post-core application will be completed at the seventh day after postoperative pain evaluation.
Other intervention name(s): 1-visit RCT; 2-visit RCT
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: after root canal treatment, post and core application in the first group and only root canal treatment in the second group post operative pain intensity will be assessed at 24, 48, and 72-h; 7-day follow-up.
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Dental posts; postoperative pain; single-visit root canal treatment; two-visit root canal treatment; vibration
Protecting Health Care Workers During the COVID-19 Outbreak
Condition: Covid-19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      Preparing to deal with Covid-19 outbreak in Rajasthan, India, health care workers were given
      Ayurvedic Kadha (combination of ayurvedic herbal extracts) starting from the end of February
      2020. Then, majority of these health care workers were put on front line managing screening,
      monitoring, quarantine and treating Covid 19 patients. This real-life study aimed to
      determine the experience of health care workers who had Ayurveda kadha before starting as
      front-line workers.
    


Intervention name(s): Ayurvedic Kadha
Intervention type(s): Dietary Supplement
Intervention description(s): Kadha (also called Kwath and Kashaya) is a type of ayurvedic formulation prepared by boiling herbs in water. Water and herbs are main ingredients of these preparations. The preparation of Kadha uses dry herbs, which are dried under the sun or in the shade, as directed for the individual herb. Then, the herbs are pounded to form a coarse powder
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Health care workers at front line of Covid-19 screening, treatment and management
Pegylated Liposomal Doxorubicin or Epirubicin in Neoadjuvant or Adjuvant Chemotherapy for Breast Cancer.
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      Pegylated liposomal doxorubicin or epirubicin in neoadjuvant or adjuvant chemotherapy for
      breast cancer.
    

Detailed description: 
      This study is an real-world, multicenter, case control study about comparing pegylated
      liposomal doxorubicin Efficacy and safety of epirubicin in neoadjuvant and adjuvant
      chemotherapy for breast cancer. As this trial is a retrospective real-world study,
      investigator have given patients the dose of trial drugs based on real-world principles of
      diagnosis and treatment and their clinical experience. This trial only collects and analyzes
      patients' clinical medications, and does not interfere with patients' real-world diagnosis
      and treatment. A total of 1050 breast cancer patients are collecting from seven centers. 200
      cases in neoadjuvant and 850 cases in adjuvant group. The follow-up examinations and
      assessment of the subjects were followed by real-world medical treatment routines and the
      visits were completed according to the routine of treatment. Related check and assessments
      and collect the following data: follow-up 3years or until the disease recurs (whichever
      occurs first). Adverse events: remission or stability of adverse events caused by follow-up
      to treatment in the adjuvant treatment group, follow-up for 3 years or until recurrence of
      the disease in the neoadjuvant treatment group (whichever first occurred).
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 1050 breast cancer patients were collected from seven centers. 200 cases in
        neoadjuvant and 850 cases in adjuvant group.
      
Keywords: invasive breast cancer; neoadjuvant; adjuvant; Anthracycline
Investigate a Varnish to Protect From Erosive Toothwear
Condition: Tooth Erosion
MeSH terms: Tooth Erosion
Study type: Interventional
Phase: Phase 3

Summary: 
      This in-situ study will investigate on extracted teeth the protection of a re-formulated
      varnish containing fluoride in the same concentration as an existing approved varnish used to
      treat caries and erosion. Healthy volunteers without caries, periodontal disease or signs of
      erosive tooth wear and who give consent will be recruited to a cross-over blinded
      intervention. Custom mouthguards (splints) housing 8 sections of extracted human teeth will
      wear the appliance for 3 consecutive days and then repeat the study. Extracted teeth will be
      collected from patients needing tooth extraction for dental reasons. Their participation
      ceases when they donate the teeth. The teeth will be sterilised with hypochlorite for a
      minimum of 24 hrs and then sectioned and polished to form a 5mm x 5mm area of enamel and
      placed in the splint. The varnish, with and without fluoride, will be applied to the surface
      of the extracted teeth, allowed to dry, and then placed into the mouth of the healthy
      volunteers for 6 hours, after which, the varnish will be carefully removed. Overnight the
      splint and teeth will be kept in a clean and moist environment and replaced in the mouth the
      following day, again for 6 hours. Every 90 minutes, four times over the day, the splint will
      be removed and immersed in 1% citric acid pH 2.7 for 2 minutes. At the end of the day, 2
      sections will be removed and tested in the laboratory for hardness. The splint will be
      reinserted in the mouth again for 6 hours during which it will be immersed in the acid again
      every 90 mins. At the end of the day the samples will be removed and measured using
      profilometry. A few weeks later the process will be repeated with either the fluoride or
      non-fluoride varnish, the order being randomly determined.
    


Intervention name(s): Varnishes, Fluoride
Intervention type(s): Drug
Intervention description(s): Fluoride varnish containing 5.0% NaF
Intervention MeSH terms: Fluorides; Fluorides, Topical
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
GB001 in Adult Participants With Chronic Rhinosinusitis
Condition: Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP); Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
MeSH terms: Sinusitis; Nasal Polyps; Polyps
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2a, randomized, double-blind, placebo-controlled, multi-center study to evaluate the
      efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of GB001 compared with
      placebo over 16 weeks of treatment in patients with chronic rhinosinusitis with or without
      nasal polyposis (NP).
    


Intervention name(s): GB001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): film-coated oral tablet; film-coated oral tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: GB001; Gossamer Bio; Gossamer; Nasal Polyposis; CRSwNP; CRSsNP
Microbiota-targeted Diet for Pediatric UC
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional

Summary: 
      Ulcerative colitis is a chronic inflammatory disease primarily involving the colon and has
      long been considered to be due to a dysregulated immune response targeting the colon, and
      involves unknown environmental factors. Currently, no effective therapy targets the
      microbiota or its interaction with the colonic epithelium. Diet has a significant impact on
      the composition of the microbiota; however, no dietary intervention to date has proven
      effective for induction of remission. The primary objective of this study is to determine
      whether the Ulcerative Colitis Diet (UCD) can induce remission or response in pediatric UC
      patients with active mild to moderate UC on a stable medication.
    


Intervention name(s): Ulcerative Colitis Diet (UCD)
Intervention type(s): Other
Intervention description(s): The primary study intervention is a novel dietary intervention, the UC Diet. The UC Diet is a structured 12-week diet with a step down phase designed to remove products that allow harmful bacteria to thrive and add products that can change the bacteria in the gut to induce remission
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Leveraging Clinic to Promote Literacy in Young Children
Condition: Literacy
Study type: Interventional

Summary: 
      Our primary aim of this study is to assess the impact of an early literacy text messaging
      program (TipsByText, TbT) for parents of children between 3 to 4-years old during an office
      visit without access to preschool. To assess this aim, our objectives are to specifically
      assess (1) child literacy using the Phonological Awareness Literacy Screening Tool
      (PALS-PreK) and (2) caregiver involvement using the Parent Child Interactivity Scale (PCI)
      pre- and post-intervention, comparing with a control group not receiving the TipsByText
      intervention. A secondary outcome of this study is to compare trust among families that
      participate in the Tips by Text (TbT) Program with families that do not participate in TbT
      using the Trust Evaluation Scale. Children will complete the PALS-PreK and caregivers of the
      children will complete the PCI and Trust Evaluation Scales.
    


Intervention name(s): Tips By Text Messages
Intervention type(s): Other
Intervention description(s): Texts sent to caregivers meant to increase parent child interaction around literacy, sent to participants 3 x a week for 7 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: school readiness
Vitamin D in Egyptian Children With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 3

Summary: 
      There is an emergent evidence demonstrating the role of Vitamin D deficiency in eczema.
      Vitamin D supplementation with standard treatment yielded positive clinical outcomes for
      children and adolescents with mild and moderate AD; however, the potential benefit of vitamin
      D in severe cases remains unclear
    


Intervention name(s): Vitamin D; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Vitamin D plus topical 1% hydrocortisone cream twice daily; placebo plus topical 1% hydrocortisone cream twice daily
Other intervention name(s): plus topical 1% hydrocortisone cream twice daily
Intervention MeSH terms: Vitamin D; Hydrocortisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
An Observational Study to Evaluate the Safety and Efficacy of Pegfilgrastim (Neulasta®)
Condition: Breast Cancer Female; Breast Neoplasm Female
MeSH terms: Breast Neoplasms; Neutropenia; Febrile Neutropenia
Study type: Observational

Summary: 
      The purpose of this observational study is to evaluate real-world safety and efficacy of
      pegfilgrastim (Neulasta) administered as secondary prophylaxis in Korean female patients with
      breast cancer receiving chemotherapy regimens recently covered under national health
      insurance. This is a prospective, observational, open-label trial with a target enrollment of
      1400 subjects.

      Primary endpoint The primary aim of this study is to determine the incidence of febrile
      neutropenia.

      Secondary endpoint Major secondary endpoint include a) Incidence of bone pain, b) All adverse
      events, c) Percentage of patients with RDI (relative dose intensity) ≥ 85%
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Please refer to the inclusion criteria
      
Keywords: febrile neutropenia; neutropenia
Comparison of the Effect of Magnesium Sulfate and Dexamethasone on Postoperative Sore Throat After Spinal Surgery in Prone Position With Tracheal Intubation: a Double-blind, Randomized, Noninferiority Clinical Trial
Condition: Post Operative Sore Throat
MeSH terms: Pharyngitis
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effect of magnesium sulfate and dexamethasone on
      postoperative sore throat after spinal surgery in prone position with tracheal intubation.
    


Intervention name(s): Magnesium Sulfate; dexamethasone
Intervention type(s): Drug; Drug
Intervention description(s): Magnesium sulfate 30 mg kg-1 was infused in 100mL normal saline for 10 minutes immediately before anesthesia induction. After tracheal intubation, normal saline 1.6mL ( equivalent volume as Dexamethasone 8mg) was injected, and magnesium sulfate was continuously infused at the rate of 10 mg Kg-1 h-1 until the end of surgery. (at the time of skin closure); Normal saline 100mL was infused for 10 minutes immediately before anesthesia induction. After tracheal intubation, dexamethasone 8mg was injected, and normal saline was continuously infused at the rate of 10 mg Kg-1 h-1 until the end of surgery. (at the time of skin closure)
Intervention MeSH terms: Dexamethasone; Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Magnesium, Post operative sore throat, Prone position, Tracheal intubation
Effect of Epidural Anesthesia and Analgesia on Patients' Outcomes After Liver Resection
Condition: Hepatectomy
Study type: Interventional

Summary: 
      The purpose of this study is to analyze the effects of epidural anesthesia and analgesia on
      intraoperative clinical outcome, postoperative recovery, metabolic changes, and immune
      functions of the patients receiving open liver resection.
    


Intervention name(s): epidural anesthesia and analgesia
Intervention type(s): Procedure
Intervention description(s): A thoracic epidural catheter (T8-10) was placed in group E. A bolus of 8ml 1% lidocaine with 0.375% ropivacaine was administered 15min before skin incision, followed by 5-8 ml/hr infusion during surgery in group E.
Postoperative analgesia by PCEA in group E (concentration: 0.1% ropivacaine + 0.1μg/ml sufentanil, loading dose: 4ml, infusion rate: 8ml/hr, bolus: 4ml, 1hr limit: 16ml) and lasting for 48hr and PCIA in group G (concentration: 1μg/ml sufentanil, loading dose: 4ml, bolus: 2ml, 4hr limit: 30ml).
Both group received general anesthesia maintaining with 1-2% end tidal sevoflurane together with TCI of propofol (target plasma concentration, 2-3µg/ml), continuous infusion of remifentanil (0.10 - 0.20 μg/kg/min) and cis-atracurium intermittently as needed.
Intervention MeSH terms: Anesthetics
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Probiotics in Women With Primary Dysmenorrhoea
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study compares the effect of probiotics versus placebo in women with primary
      dysmenorrhoea
    

Detailed description: 
      This is a randomized controlled trial comparing probiotics against placebo in women with
      primary dysmenorrhoea
    

Intervention name(s): Probiotic; Placebo
Intervention type(s): Biological; Other
Intervention description(s): (Lactobacillus acidophilus, lactobacillus casei, lactobacillus lactis) and Bifidobacterium (Bifidobacterium bifidum, bifidobacterium longum, bifidobacterium infantis) lactose, sugar, milk powder, oligosaccharides, ascorbic acid, citric acid, maltodextrin, and orange flavor; lactose, sugar, milk powder, oligosaccharides, ascorbic acid, citric acid, maltodextrin, and orange flavor
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized placebo-controlled trial
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: probiotics
Incidence of Venous Thromboembolism in Children Undergoing Elective Neurosurgical Procedures
Condition: Deep Vein Thrombosis
MeSH terms: Thrombosis; Thromboembolism; Venous Thromboembolism; Venous Thrombosis
Study type: Observational

Summary: 
      The purpose of this study is to determine how frequently children undergoing elective
      neurosurgical procedures develop blood clots in the deep veins of the legs while
      hospitalized. The information gained from this study will help us determine when children
      children need to receive therapy to help prevent this type of blood clot from forming.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        100 children between the ages of 1 month-12 years having an elective neurosurgical
        procedure at James Whitcomb Riley Hospital for Children.
      
Keywords: Deep vein thrombosis; Children; Pediatric; Anti-coagulant; Neurosurgical procedures; Blood Clot