bioihbjkbjnl/mcl2 huggingface dataset:
Assessment of Bacterial Loads of Essix Retainers in Patients Under Retention Therapy
Condition: Orthodontic Appliance Complication
Study type: Interventional

Summary: 
      The aim of this study is to investigate the bacterial loads present on essix retainers in
      patients' contention therapy. Patients are randomly divided into three groups, depending on
      the product used for the cleansing of the retainers: Geldis, Polident tablets and water.
      Microbiological samples were taken from the retainers at the baseline, after 1 and after 2
      months, together with Bleeding Index, Plaque Index, BEWE Index and Schiff Air Sensitivity
      test.
    

Detailed description: 
      The aim of this study is to investigate the bacterial loads present on essix retainers in
      patients' contention therapy. Patients who wear essix retainers for contention therapy are
      randomly divided into three groups, depending on the product used for the cleansing of the
      retainers: Geldis, Polident tablets and water. Periodontal evaluation and microbiological
      samples are conducted at the baseline, after 1 and after 2 months.

      Bacterial loads are collected from essix retainers, whereas Bleeding Index, Plaque Index,
      BEWE Index and Schiff Air Sensitivity test are assessed from the patients' mouth.
    

Intervention name(s): Retainers' Cleansing with Geldis®; Retainers' Cleansing with tablets; Retainers' cleansing with water
Intervention type(s): Other; Other; Other
Intervention description(s): Patients will clean their essix retainers with Geldis® using a toothbrush every night for 2 months.; Patients will leave their essix retainers in a glass with water and Polident tablets every night for 2 months.; Patients will brush their essix retainers with a toothbrush under water every night for 2 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: oral microbiota; essix retainer; periodontal assessment
The Effect of the SNS-Based Feeding on Transition to Exclusive Breastfeeding in Preterm Infants
Condition: Breastfeeding; Preterm Infant; Sucking Behavior
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      This study investigated the effect of the Supplemental Nursing System (SNS)-based feeding on
      the time to transition to exclusive breastfeeding, sucking success, and the time to discharge
      in preterm infants
    

Detailed description: 
      Nutrition is a critical problem in preterm infants. They should initially be enterally fed
      because they have poor sucking-swallowing-breathing coordination. Once a preterm infant
      develops that coordination, enteral feeding should be discontinued immediately. Then, the
      preterm should switch to oral feeding (breastmilk). However, preterm infants are not good at
      sucking because they get tired too quickly, have poor sucking skills, and lack enough
      experience. Therefore, we must use alternative supplemental feeding methods (bottle, spoon,
      dropper, cup, breastfeeding support system, and finger feeding) until preterm infants mature
      enough to meet their daily nutritional needs by breastfeeding alone (exclusive
      breastfeeding).

      The Supplemental Nursing System (SNS) is an alternative supplemental feeding method that
      supports the development of sucking skills while providing the preterm infant's nutritional
      needs. This study investigated the effect of the Supplemental Nursing System (SNS)-based
      feeding on the time to transition to exclusive breastfeeding, sucking success, and the time
      to discharge in preterm infants.
    

Intervention name(s): MEDELA Supplemental nursing system
Intervention type(s): Device
Intervention description(s): The experimental group participants were fed based on the MEDELA Supplemental Nursing System, which consists of a syringe/container and a feeding catheter. One end of the feeding probe is in the syringe/container, while the other is fixed to the mother's nipple through a plaster. MEDELA SNS is a sterile product with an adjustable breast milk flow system and neck strap. It is bisphenol A (BPA) free. All its parts are in direct contact with breast milk. This system allows the baby to both suck and feed (MEDELA Supplemental Nursing System, 2018).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomized into the experimental and control groups using a block randomization method. Research shows that gestational age and sucking experience affect the sucking behavior of preterm infants (Kaya and Aytekin, 2017; Yildiz and Arikan, 2012). Therefore, gestational age (30-32 and 33-34 weeks), gender (girls and boys), and LATCH scores (0-2, 3-6, and 7-10 points) were used for block randomization. The blocks were repeated three times in each group. Thirty-six participants were assigned to each group. A 2X2X3X3 blocked randomization list was developed using an online randomization tool (Sealed Envelope Ltd, 2018).
Masking: Single (Investigator)
Primary purpose: Supportive Care
Peripheral Oxytocin and Touch
Condition: Healthy Adults
Study type: Interventional
Phase: Phase 2

Summary: 
      Research shows that slow gentle skin stroking can activate special sensory nerves in the skin
      that elicit relaxing effects on the body and mind, similar to the effects of the hormone
      oxytocin. Studies also suggest that gentle stroking may even release oxytocin in the skin.
      However, we do not know what oxytocin does in the skin and how it affects nerves that send
      pleasant touch or pain signals to the brain. The proposed study will determine how
      individuals perceive gentle stroking and experimental pain before and after a skin injection
      of oxytocin compared to a placebo injection.
    


Intervention name(s): Pitocin
Intervention type(s): Drug
Intervention description(s): At each session, 4mcg/2ml oxytocin or 2ml isotonic saline (0.9% sodium chloride; placebo control) will be injected into the middle of the dorsal forearm. Sessions will be separated by at least 48 hours to ensure drug clearance.
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Donepezil 10 mg Tablets Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to compare the rate and extent of absorption of donepezil 10
      mg tablet (test) versus Aricept® (reference), administered as 1 x 10 mg tablet under fed
      conditions.
    

Detailed description: 
      Criteria for Evaluation: FDA Bioequivalence Criteria

      Statistical Method: FDA Bioequivalence Statistical Methods
    

Intervention name(s): Donepezil; Aricept®
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg Tablet; 10 mg Tablet
Other intervention name(s): Donepezil (generic name)
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Healthy Subjects; Donepezil
Study To Evaluate Efficacy And Safety Of An Additional Dose Of Celecoxib (YM177) In Patients With Post-Tooth Extraction Pain
Condition: Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate efficacy and safety of additional dose of celecoxib, as compared to placebo, in
      patients with post lateral mandibular impacted third molar tooth extraction pain.
    


Intervention name(s): Celecoxib; Celecoxib; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Initial dose: Celecoxib 200mg tablet x 2 will be administrated during a period from 1 to 2 hours post lateral mandibular impacted third molar tooth extraction in subjects with "moderate pain" or "severe pain"rated as 45.0 mm or more on the VAS; Additional dose: Celecoxib 200mg tablet x 1 will be administrated during a period from 5 to 12 hours post-initial dose of Celecoxib 400mg in subjects who require an additional analgesic dose for any pain; Additional dose: Placebo (tablet) will be administrated during a period from 5 to 12 hours post-initial dose of Celecoxib 400mg in subjects who require an additional analgesic dose for any pain
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Acute pain after oral surgery lateral mandibular Impacted third molar tooth extraction
Host Modulatory Effects of β-glucan on Localized Aggressive Periodontitis
Condition: Localized Aggressive Periodontitis
MeSH terms: Periodontitis; Aggressive Periodontitis; Aggression
Study type: Interventional
Phase: Phase 4

Summary: 
      combining the non-surgical therapy with a well-tolerated substance that can stimulate
      protective immune responses like B-glucan, might effectively mount resolution pathways
      contributing to resolving of the chronic lesion observed in aggressive forms of periodontal
      disease.
    

Detailed description: 
      Aim: To investigate the efficacy of β-glucan supplementation to non-surgical periodontal
      therapy in localized aggressive periodontitis (LAP) patients.

      Method: 30 subjects were randomly and equally assigned to receive scaling and root planing;
      either with placebo pills (Group I) or β-glucan (100 mg/once a day) (Group II), for 40 days.
      Subjects were clinically monitored on day 0 and day 91. Gingival samples were harvested from
      hopeless teeth sites to be investigated histologically and immunohistochemically using matrix
      metalloproteinase (MMP)-1 and 9 antibodies form each patient; at the same time intervals.
    

Intervention name(s): β-1,3/1,6-D-glucan; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days.; 15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days.
Other intervention name(s): Imurril capsules 100mg; Empty capsules filled with carbohydrates
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Taxotere New Indication - Gastric Cancer Treatment Registration Trial
Condition: Stomach Neoplasms
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective:

      To detect a statistically significant increase in time to progression (TTP) of disease for
      the test group (Taxotere® [Docetaxel] combined with cisplatin and 5-fluorouracil [TCF])
      relative to the control group (Cisplatin combined with 5-fluorouracil[CF])

      Secondary objectives:

        -  To detect a statistically significant increase in overall survival (OS) for the test
           group relative to the control group.

        -  To compare response rate (RR), time to treatment failure (TTF), duration of responses,
           safety profiles, quality of life (QOL), and disease-related symptoms.
    


Intervention name(s): 5-fluorouracil; Cisplatin; Docetaxel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 600 mg/m²/day intravenous; 60 mg/m² or 75 mg/m² intravenous; 60 mg/m² intravenous
Intervention MeSH terms: Docetaxel; Fluorouracil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Tenofovir in Late Pregnancy to Prevent Vertical Transmission of Hepatitis B Virus
Condition: Hepatitis B Infection; Chronic Infection; Viremia
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis B; Viremia; Persistent Infection; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Immunoprophylaxis failure of hepatitis B virus (HBV) leading to vertical transmission remains
      a concern and has been reported in approximately 8-15% of infants born to hepatitis B e
      antigen (HBeAg) positive mothers with high levels of HBV DNA. Maternal HBV DNA > 6log10
      copies/mL (or >200,000 IU/mL) is the major risk for the mother-to-child transmission. Prior
      observational studies have shown that antiviral therapy including lamivudine or telbivudine
      use during late pregnancy can safely reduce the rate of vertical transmission in this special
      population compared to untreated patients.

      Tenofovir Disoproxil (TDF), a pregnancy category B medication, reduces HBV DNA and normalizes
      serum alanine aminotransferase (ALT) in chronic hepatitis B patients (CHB) with few adverse
      effects. Two aspects on tenofovir use in pregnancy will be evaluated prospectively in this
      study:

        1. The data on its tolerability and safety in HBeAg+ pregnant women with HBV DNA > 6log10
           copies/mL (or > 200,000 IU/mL) during late pregnancy and infants.

        2. Its efficacy in the reduction of HBV vertical transmission rate.
    

Detailed description: 
      Eligible mothers will be randomized (1:1) to either TDF-treated group or untreated group with
      about 100 subjects in each arm. The treatment group will receive TDF starting at week 30-32
      of gestation until week 4 postpartum; follow up will continue until post-partum week 28 and
      infants age of 28 weeks. Untreated group will receive the standard of care with similar
      follow-up schedule as the treatment group.
    

Intervention name(s): TDF treatment
Intervention type(s): Drug
Intervention description(s): About 100 mothers treated with tenofovir from 30-32 weeks of pregnancy to the week 4 of postpartum, then observed to the end of the study at post-partum week 28, paired infants received standard HBV prophylaxis.
Other intervention name(s): Viread, Tenofovir, TDF, Hepatitis B-IgG, Hepatitis B vaccine
Intervention MeSH terms: Tenofovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis B; Vertical transmission; Pregnancy; Antiviral treatment
DAA Based Therapy for Recently Acquired Hepatitis C (DARE-C)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      To examine the safety and efficacy of response guided triple therapy (PEG-IFN, Ribavirin,
      Telaprevir) for the treatment of early chronic Hepatitis C Virus (HCV) infection.
    

Detailed description: 
      DARE-C is a prospective open label multi-centre pilot study examining the safety and efficacy
      of response guided triple therapy (PEG-IFN, Ribavirin and Telaprevir) for the treatment of
      early chronic HCV genotype 1 infection in individuals with and without HIV infection.
    

Intervention name(s): TPV/PEG-IFN/RBV
Intervention type(s): Drug
Intervention description(s): Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly.
Other intervention name(s): Telaprevir brand name: INCIVO; Ribavirin brand name: COPEGUS; PEG-IFN brand name: PEGASYS
Intervention MeSH terms: Ribavirin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; Individualised therapy; Response-guided therapy; Telaprevir; PEG-IFN; Ribavirin; Hepatitis
Effects of Dexmedetomidine on the Liver Injury After Hepatectomy
Condition: Ischemia-reperfusion Injury
MeSH terms: Reperfusion Injury; Ischemia
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate whether dexmedetomidine reduce liver injury after hepatectomy. During
      hepatectomy, surgeons always took inflow occlusion to reduce blood loss with Pringle
      maneuver. A few clinical studies had shown dexmedetomidine could reduce ischaemia/reperfusion
      (IR) injury caused by the secretion of reactive oxygen species and inflammatory cytokines.
      Glutathione-S-transferase (GST) was a sensitive and specific marker for hepatic injury in
      several studies before. So the investigator decided to use it as the primary endpoint.
      Besides, in our center, there are some liver resection surgeries that didn't need occlusion.
      So it can serve the best placebo for determine the the actual effect of dexmedetomidine on
      the IR injury in further subgroup analysis.
    

Detailed description: 
      The purpose of our study is to compare liver injury with dexmedetomidine. The enrolled
      patients were randomized into two group. In the study group, dexmedetomidine, diluted in 0.9%
      sodium chloride with the concentration of 4 ug ml-1 is administered with an loading dose of
      0.5ug kg-1 of 10 min, and maintained with infusion rate of 0.5 ug kg-1 h-1. While, 0.9%
      sodium chloride serves as the placebo with the same loading dose and infusion rate in the
      control group. The infusion is ceased after the resection of the hepatic issues.

      GST is a sensitive and specific marker for hepatic injury in several studies before and is
      taken as the primary endpoint. And the investigator use other inflammatory cytokines
      reflecting the systemic inflammatory response in serum. Besides these, the investigator
      observe the hemodynamic changes during the operation time and complications related with
      anesthesia and surgery.
    

Intervention name(s): dexmedetomidine; 0.9% sodium chloride
Intervention type(s): Drug; Drug
Intervention description(s): dexmedetomidine 2mg is diluted in 0.9% sodium chloride with the concentration of 4 ug ml-1 is administered with an loading dose of 0.5ug kg-1 of 10 min, and maintained with infusion rate of 0.5 ug kg-1 h-1. The infusion is ceased after the resection of the hepatic issues.; 0.9% sodium chloride is administered with an loading dose of 0.5ug kg-1 of 10 min, and maintained with infusion rate of 0.5 ug kg-1 h-1. The infusion is ceased after the resection of the hepatic issues.
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
Condition: Healthy Volunteers (Meningococcal Infection)
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study was to describe the safety profile of Meningococcal
      Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) Conjugate Vaccine and
      Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 (MENVEO®)
      Conjugate Vaccine when administered concomitantly with routine pediatric vaccines in healthy
      infants and toddlers.
    

Detailed description: 
      Study duration per participant was approximately 16 months, which includes a safety follow-up
      contact at 6 months after the final vaccination.
    

Intervention name(s): Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine (MenACYW Conjugate vaccine); Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®); Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine; Pneumococcal 13-valent Conjugate Vaccine; Rotavirus Vaccine; Hepatitis B Vaccine; Measles, Mumps, and Rubella Virus Vaccine; Varicella Virus Vaccine
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Pharmaceutical form: Liquid solution. Route of administration: Intramuscular; Pharmaceutical form: Lyophilized powder combined with liquid components Route of administration: Intramuscular; Pharmaceutical form: Liquid DTaP-IPV to reconstitute lyophilized ActHIB Route of administration: Intramuscular; Pharmaceutical form: Suspension for injection Route of administration: Intramuscular; Pharmaceutical form: Oral solution Route of administration: Oral; Pharmaceutical form: Suspension for injection Route of administration: Intramuscular; Pharmaceutical form: Lyophilized live virus vaccine Route of administration: Subcutaneous; Pharmaceutical form: Suspension for injection Route of administration: Subcutaneous
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus
Condition: Barrett's Esophagus
MeSH terms: Barrett Esophagus
Study type: Observational

Summary: 
      The purpose of this study is to determine the association between acid reflux and cell
      changes in Barrett's esophagus.

      Specific aim 1: To test the hypothesis that controlled acid reflux is associated with lesser
      degree of stromal activation.

      Specific aim 2: To test the hypothesis that stromal fibroblast derived growth factors drive
      BE epithelial proliferation.
    


Intervention name(s): 24 hour pH study and upper endoscopy (EGD)
Intervention type(s): Procedure
Intervention description(s): All subjects enrolled will undergo 24 hour pH followed by EGD.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Those diagnosed with barrett's esophagus confirmed by pathology with no dysplasia or low
        grade dysplasia
      
Biospecimen description: 
      Tissue specimens from Barrett's esophagus
    
Keywords: Barrett's esophagus