bioihbjkbjnl/mcl2 huggingface dataset:
In Situ Caries of Fluoride Toothpastes
Condition: Healthy Subjects; Partial Denture Wearers; Caries
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is to evaluate the effect of fluoride dentifrices on enamel with artificial caries
      lesions in an in situ model.
    

Detailed description: 
      Topical fluorides have been proven to be clinically effective in the prevention of dental
      caries. It is generally agreed that anti-caries effect of fluoride (F) is mainly by
      decreasing the rate of enamel demineralization and enhancing the rate of enamel
      remineralization. An in-situ Surface Micro-hardness (SMH) test is widely used to evaluate
      enamel demineralization and remineralization during the caries process. The aim of this study
      was to evaluate the efficacy of toothpaste formulations containing fluoride from different
      sources [sodium fluoride (NaF) and sodium monofluorophosphate (NaMFP)] using an in situ
      caries model.
    

Intervention name(s): Sodium fluoride toothpaste; Placebo toothpaste
Intervention type(s): Drug; Drug
Intervention description(s): Various fluoride toothpastes containing 1350 ppm F, 1450 ppm F, 1400 ppm F and 250 ppm F; Fluoride free toothpaste (0 ppm F)
Other intervention name(s): Fluoride
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: remineralization; enamel; fluoride; caries; in situ
An Open Label Non-Interventional Evaluation of the Effect of Adjuvant Hormonal Treatment of Postmenopausal Women Wih Early Breast Cancer With Aromatase Inhibitors on Bone Mineral Density and Bone Fracture Rate in Daily Practice
Condition: Breast Cancer; Osteoporosis
MeSH terms: Breast Neoplasms; Osteoporosis; Fractures, Bone
Study type: Observational

Summary: 
      The aim of this study is to determine the effect of aromatase inhibitors therapy on bone
      mineral density and compare it to the effects of tamoxifen and no hormonal therapy.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Institute of Oncology
      
Keywords: breast cancer; aromatase inhibitors; bone mineral density; osteoporosis
An Effectiveness and Safety 6 Months Study of 3 Injections One Week Apart of SYNOLIS VA 40/80 in the Treatment of Symptomatic Knee Osteoarthritis
Condition: Osteo Arthritis Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Multicentre, independent assessment study on SYNOLIS VA 40/80 over a period of 24 weeks
    


Intervention name(s): SYNOLIS VA 40/80
Intervention type(s): Device
Intervention description(s): Three 2mL injections of SYNOLIS VA 40/80, one week apart
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osteoarthritis; Knee Osteoarthritis; Hyaluronic acid
Serum Cortisol Levels in Patients With Anxiety and Depression With Symptomatic Oral Lichen Planus
Condition: Oral Lichen Planus Related Stress
MeSH terms: Lichen Planus, Oral; Lichen Planus
Study type: Interventional

Summary: 
      Oral lichen planus (OLP) is a T-cell mediated chronic immunological disease directed to a
      still unknown antigen. It is a mucocutaneous and a psychosomatic disorder, with unknown
      prevalence rate; however studies suggest an incidence of 0.02 to 0.22% among the Indian
      population. 75% of patients with cutaneous lichen planus also experience oral lesions and may
      be precipitated or exacerbated by psychosocial stressors.

      In conditions like pain, anxiety and stress, many metabolic and endocrine changes occur in
      the body, the most common effect of which is increased cortisol level in blood. This hormone
      is a 21-carbon corticosteroid secreted by adrenal cortex and regulates the metabolism of
      carbohydrates, fats, proteins and water. Also known as stress hormone, cortisol is a decisive
      index in stressful situations.

      This study is intended to correlate the serum cortisol levels with anxiety and depression in
      patients with symptomatic oral lichen planus. This study attempts to evaluate psychological
      anxiety and depression in oral lichen planus subjects using Hospital Anxiety and Depression
      Scale ( HADS) and correlating with their serum cortisol levels.

      To understand and explore the etiopathogenesis for better management of oral lichen planus.
    

Detailed description: 
      Oral lichen planus (OLP) is a T-cell mediated chronic immunological disease directed to a
      still unknown antigen. It is a mucocutaneous and a psychosomatic disorder, with unknown
      prevalence rate; however studies suggest an incidence of 0.02 to 0.22% among the Indian
      population. 75% of patients with cutaneous lichen planus also experience oral lesions and may
      be precipitated or exacerbated by psychosocial stressors.

      In conditions like pain, anxiety and stress, many metabolic and endocrine changes occur in
      the body, the most common effect of which is increased cortisol level in blood. This hormone
      is a 21-carbon corticosteroid secreted by adrenal cortex and regulates the metabolism of
      carbohydrates, fats, proteins and water. Also known as stress hormone, cortisol is a decisive
      index in stressful situations.

      This study is intended to correlate the serum cortisol levels with anxiety and depression in
      patients with symptomatic oral lichen planus.
    

Intervention name(s): venepuncture
Intervention type(s): Procedure
Intervention description(s): for both the groups, HADS questionnaire will be administered to assess the levels of anxiety and depression. The placebo group ( group A) will not be having subjects suffering from oral lichen planus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Study in Subjects With PAH and PH Secondary to IPF Using Inhaled GeNOsyl.
Condition: Pulmonary Arterial Hypertension; Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Idiopathic Pulmonary Fibrosis; Hypertension; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2 open label, dose escalation study to find the minimally and maximum effective dose
      (dose beyond which no further effect on PVR is seen) of inhaled nitric oxide generated by the
      GeNOsyl® System compared to placebo.
    

Detailed description: 
      Up to 54 subjects undergoing RHC are planned in this study, and shall include subjects
      meeting eligibility criteria classified as WHO Group 1 PAH or WHO Group 3 IPF-PH. Subjects
      will receive inhaled nitric oxide from the GeNOsyl® System to characterize the hemodynamic
      response and evaluate safety and tolerability.

      Dose cohorts of approximately 5, 15, and 20 ppm nitric oxide in air will be studied.
      Different dose levels will be achieved by varying the flow rate of the drug substance (80 ppm
      NO2 in balance air) delivered to the subject via nasal cannula. Each subject will receive two
      different doses of inhaled nitric oxide separated by a placebo (medical grade air or
      supplemental oxygen) washout. Eligible subjects will be assigned to a dosing cohort in an
      escalating manner to receive study drug (80 ppm nitric oxide in air.)
    

Intervention name(s): Inhaled Nitric Oxide; Inhaled Nitric Oxide; Inhaled Nitric Oxide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Inhaled nitric oxide 80 ppm via nasal cannula at 1 LPM for 15 minutes followed by placebo washout of 15 minutes inhalation of medical grade air (or prescribed supplemental oxygen), and then inhaled nitric oxide 80 ppm via nasal cannula at 1 LPM; Inhaled nitric oxide 80 ppm via nasal cannula at 1 LPM for 15 minutes followed by placebo washout of 15 minutes inhalation of medical grade air (or prescribed supplemental oxygen), and then inhaled nitric oxide 80 ppm via nasal cannula at 2 LPM; Inhaled nitric oxide 80 ppm via nasal cannula at 1 LPM for 15 minutes followed by placebo washout of 15 minutes inhalation of medical grade air (or prescribed supplemental oxygen), and then inhaled nitric oxide 80 ppm via nasal cannula at 4 LPM
Other intervention name(s): GeNOsyl; GeNOsyl; GeNOsyl
Intervention MeSH terms: Nitric Oxide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PAH; PH IPF
18841- Sun Protection Factor Assay
Condition: Sunscreening Agent
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): Coppertone (BAY 987517)
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.(Formulation- SR16-07)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of the Effects of Remifentanil and Dexmedetomidine Administered Under General Anesthesia in Rhinoplasty
Condition: Rhinoplasty; Dexmedetomidine; Remifentanil
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators compared the effects of remifentanil and dexmedetomidine administered under
      general anesthesia on hemodynamics, postoperative pain, recovery, postoperative nausea,
      vomiting, shivering, patient's and surgeon's satisfaction in patients undergoing elective
      rhinoplasty. A single-center, prospective, blinded, randomized controlled trial. After the
      approval of the hospital ethics committee (KA22/12), fifty volunteers aged 18-65 years who
      underwent rhinoplasty under elective conditions accepted the study in the American Society of
      Anesthesiologists (ASA) I-III class. The patients were randomly divided into the remifentanil
      group (group R) and the dexmedetomidine group (group D). Group R (n=25) was initially to
      receive remifentanil 0.01-0.2 g/kg/min without intraoperative loading. Group D (n=25)
      dexmedetomidine, was initiated with a bolus of 1 mg/kg and received 0.2-0.7 g/kg per hour as
      an infusion during surgery.
    


Intervention name(s): Remifentanil 2 MG; dexmedetomidine
Intervention type(s): Drug; Drug
Intervention description(s): Remifentanil is an opioid; it has sedative, analgesic, and sympatholytic properties.; Studies show that dexmedetomidine is superior to currently commonly used remifentanil in terms of intraoperative blood pressure control and postoperative pain.
Dexmedetomidine, an alpha-2-adrenoceptor agonist, has sympatholytic, sedative, anesthetic, analgesic, and vasoconstrictor effects. It lowers blood pressure by decreasing plasma norepinephrine and epinephrine levels, thereby reducing intraoperative bleeding. Dexmedetomidine is defined as an analgesic that is now widely used to induce and maintain anesthesia and to control postoperative pain, and is defined as an analgesic that does not cause respiratory depression and neurocognitive impairment. Many studies have shown that the use of perioperative dexmedetomidine reduces the stress response to anesthetic induction and surgery and provides hemodynamic stability.
Intervention MeSH terms: Dexmedetomidine; Remifentanil
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: Remifentanil; dexmedetomidine; pain; recovery; shivering
Evaluation of Pressure Sense Threshold and Tactile Sensation After Lidocaine Iontophoresis Using Interferential Current
Condition: Interferential Current Drug Delivery
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Drug delivery is conducted through various methods such as injection, phonophoresis, and
      iontophoresis. Iontophoresis is defined as the noninvasive delivery of active ions through
      epidermis using direct current. The direct current has some disadvantages such as skin
      burning and limited time of application. Interferential current is a kind of alternating
      currents without limitations of direct current; so the purpose of this study was to
      investigate and compare the effects of Lidocaine, interferential current and Lidocaine
      iontophoresis using interferential current.
    

Detailed description: 
      Pressure, tactile, and pain thresholds were evaluated before and after the application of
      Lidocaine, interferential current and Lidocaine iontophoresis using interferential current.
      Pressure threshold was investigated with a Pesula. Pesula is a pen-like scaled mechanical
      device that measures the skin pressure threshold. Pesula was pressed to the skin and pressure
      threshold was measured in mm. Pain and tactile thresholds were investigated using an
      electrical stimulator.The intensity was gradually increased to the extent that the
      participant reported a tingling sensation. The displayed intensity was considered as the
      tactile sense threshold. Then, the intensity was increased to the extent to be intolerable
      for the participant and this intensity was considered as the maximum pain threshold. The
      thresholds were recorded in milliampere.

      Lidocaine iontophoresis using interferential current can increase perception threshold of
      pain, and pressure sense more significantly in comparison to the application of Lidocaine and
      interferential current alone.
    

Intervention name(s): iontophoresis of Lidocaine 10% with interferential current (Dynatron 438); Lidocaine 10% was sprayed at the identified region; interferential current
Intervention type(s): Device; Drug; Device
Intervention description(s): drug delivery through interferential current.
Other intervention name(s): Dynatron 438, Enraf Nonius Comp., Netherlands; Xylocaine 10% spray, AstraZeneca, Korea; Dynatron 438, Enraf Nonius Comp., Netherlands
Intervention MeSH terms: Lidocaine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Drug Delivery; Iontophoresis; Lidocaine; Pressure; Tactile perception
Effect of Rifampin and Efavirenz on the Pharmacokinetics of Fedratinib in Healthy Adult Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 2-part study to evaluate the effect of multiple doses of rifampin or efavirenz on
      the PK, safety, and tolerability of single doses of fedratinib in healthy subjects. Each
      study part will consist of a nonrandomized, fixed-sequence, open-label design. The study
      parts can be run in any order or in parallel. Subjects may participate in one part only. For
      each part, subjects will participate as follows:

        -  Screening

        -  Treatment period (includes baseline)

        -  Follow-up telephone call (4 days [± 2 days] after discharge) During the study, blood
           samples will be collected at prespecified times for PK. Subject safety will be monitored
           throughout the study.
    


Intervention name(s): Fedratinib; Rifampin; Efavirenz
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Fedratinib; Rifampin; Efavirenz
Intervention MeSH terms: Efavirenz; Rifampin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Subject; Fedratinib; Rifampin; Efavirenz; Drug Interaction
The Effect of Portable AR on Tooth Brushing Skill for Elementary School Students
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of this study An augmented reality (AR) simulation toothbrushing machine was
      developed to train proper brushing technique for children. The investigators aimed to
      evaluate the effects of AR brushing machine on knowledge of dental clearing skill,
      self-efficacy and dental plaque control in elementary schoolchildren in Taiwan.
    

Detailed description: 
      A quasi-experimental design was conducted; ten intervention schools (AR group) and ten
      comparison schools were selected from elementary schools. Overall, grade 3-6 students in the
      AR group (n = 290) and the traditional group (n = 311), respectively. Students in the AR
      group received a two-time repeated AR-based training for 30 minutes at two-week intervals.
      Students in the CG received traditional classroom-based teaching. Baseline and follow-ups
      information was collected using dental plaque examinations and questionnaires. The
      generalized estimating equations(GEE) were used to evaluate the outcomes between two groups
      over time.
    

Intervention name(s): AR-toothbrush machine; Teach proper brushing skills
Intervention type(s): Device; Behavioral
Intervention description(s): Student in AR group received a two-time repeated AR-based training for 30 minutes at two-week intervals. The AR-based training system (PVIX Oral, EPED) digitized the steps of the toothbrushing technique applying optical tracking technology to enable the participants to obtain immediate scoring after the completion of practice. The scoring depends on the level of removing simulated dental plaque. The AR system was equipped with an optical tracking unit, a 3D training head model, and a wireless toothbrush. The toothbrushing practice time for the upper and lower jaw is 3 minutes, respectively. A tooth-brushing song played while the students implemented.; Students in the traditional group received a two-time repeated 10-minute lesson regarding proper toothbrushing skills in the classroom at two-week intervals. The students were taught by a well-trained dental hygienist using teaching aids (such as dental models, and toothbrushes).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Augmented reality; dental plaque; schoolchildren
GIP Receptor Antagonist Studies in Humans
Condition: Glucose Metabolism
Study type: Interventional

Summary: 
      Antagonizing GIP effects during hyperglycaemia in healthy subjects and measurements of
      insulin secretion.
    

Detailed description: 
      Aim: To evaluate the GIP receptor antagonizing effect of peptide-based competitive GIP
      receptor antagonist GIP-A (vs. saline (placebo)) in 10 healthy subjects during 1 hour
      hyperglycaemic clamps with and without concomitant iv infusion of GIP[1-42]. The intention is
      to establish GIP-A as a tool to eliminate glucose-dependent insulinotropic GIP signalling.

      The study consists of four experimental days (A-D) with assessment of beta cell function
      during 12 mM-hyperglycaemic clamps with concomitant infusions of A) GIP[1-42], B) GIP-A, C)
      GIP[1-42] + GIP-A, or D) saline (placebo).
    

Intervention name(s): GIP-A; GIP(1-42); Saline
Intervention type(s): Drug; Drug; Other
Intervention description(s): GIP receptor antagonist; GIP receptor agonist; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: GIP; GIP receptor antagonist
Pharmacist Follow-up, a Qualitative Study of Patient Experience
Condition: Patient Satisfaction; Patient Preference
MeSH terms: Heart Diseases; Coronary Disease
Study type: Observational

Summary: 
      A pharmacist follow-up procedure is under development. Patients with coronary heart disease
      (CHD) is being followed up by a pharmacist for one year with three meetings; at discharge
      from hospital, after three months and after one year. The evaluation is basically based on
      quantitative measures as achievement of therapeutic goals, number of drug related problems
      detected, hospitalisations etc. However, the patients' own experience with the follow-up
      procedure cannot be evaluated using these measures. Thus, a qualitative approach is needed.
      In this study, a total of four patients participating in the follow-up will be included and
      interviewed. A semistructured interview guide will be used. Interviews will be taped,
      transcribed and analyzed with the intention to explore how patients experience the follow-up
      from the pharmacist. A thoruough content analysis will be performed. Patients included must
      have met the pharmacist at least twice. The pharmacist in charge of the follow-up will
      recruit patients and hand out study information. Patients will reply to the principal
      investigator of the study and thus kept anonymous for the pharmacist in charge of the
      follow-up. No pressure will be put on the patients to join, but it will be emphasized that it
      will help evaluating the procedure.
    

Detailed description: 
      See full publication on http://www.biomedcentral.com/1756-0500/7/197 Garcia et al. BMC
      Research Notes 2014, 7:197
    

Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Patients included in the study "Pharmacist follow-up of patients with CHD".
      
Keywords: Qualitetive interview; Coronary heart disease (CHD); Patient experience; Patient perception
Preemptive Dexamethasone , Paracetamol on Postoperative Period Following Adeno-tonsillectomy in Pediatric .
Condition: Analgesia
Study type: Interventional
Phase: Phase 2

Summary: 
      Tonsillectomy is one of the most common surgical operations performed on children, and it is
      frequently linked with an increased risk of complications such as acute discomfort when
      swallowing and postoperative nausea and vomiting (PONV).The most prevalent causes for
      postponing discharge home are poorly managed pain and PONV.
    

Detailed description: 
      Tonsillectomy is one of the most common surgical operations performed on children, and it is
      frequently linked with an increased risk of complications such as acute discomfort when
      swallowing and postoperative nausea and vomiting (PONV). The most prevalent causes for
      postponing discharge home are poorly managed pain and PONV. As a result, these occurrences
      should be avoided and managed utilizing a multimodal strategy Because of its low cost and
      adequate safety profile in the treatment of post-tonsillectomy pain, acetaminophen is
      presently regarded the fundamental analgesic in this situation. Furthermore, acetaminophen
      has been recommended for use in children, and its pharmacological safety in this age group
      has been shown. Dexamethasone is another medication that is used to reduce postoperative pain
      and PONV in various procedures.
    

Intervention name(s): paracetamol; Dexamethasone; normal Saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): patients will receive intravenous paracetamol 30mg/kg (max 90 mg/kg/day); patients will receive dexamethasone 0.5mg/kg IV.; patients will receive placebo 10 ml normal saline IV.
Intervention MeSH terms: Acetaminophen; Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: analgesia; dexamethasone; paracetamol