bioihbjkbjnl/mcl2 huggingface dataset:
Influence of Gender Specific Differences of Saliva Composition on the Development of Dental Erosion - an In-situ Study
Condition: Dental Erosion
MeSH terms: Tooth Erosion
Study type: Observational

Summary: 
      Healthy volunteers are observationally wearing an intraoral device with bovine tooth samples
      once for two hours. Afterwards, Calcium release from the bovine enamel and dentin samples is
      measured after extraoral erosion.

      Total protein concentration within the formed salivary pellicles on the bovine samples is
      determined. Further Salivary parameters (unstimulated and stimulated saliva flow rate, pH,
      buffer capacity, albumin and total protein content as well as concentration of inorganic
      calcium, phosphate and fluoride) are being measured.

      The aim of this study is to investigate whether gender differences in the salivary
      composition correlate with predisposition to erosion.
    


Intervention name(s): Wearing of an intraoral device with bovine tooth samples
Intervention type(s): Other
Intervention description(s): Wearing of an intraoral device with bovine tooth samples
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Exploratory study
      
Biospecimen description: 
      Saliva samples are obtained and retained for 10 years.
A Study to Assess the Bioequivalence of Aprepitant and Fosaprepitant and the Effect of Food on Aprepitant Bioavailability (0869-165)
Condition: Chemotherapy-Induced Nausea and Vomiting
MeSH terms: Vomiting
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the bioequivalence of single oral doses of aprepitant (MK0869) to a
      single intravenous infusion of fosaprepitant (MK0517) and also determine the effect of food
      on the bioavailability of oral aprepitant.
    


Intervention name(s): aprepitant 165 mg; Comparator: aprepitant 185 mg; Comparator: fosaprepitant 150 mg; Comparator: aprepitant with food
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single dose of aprepitant 165 mg tablet in the fasted state during treatment period 1,2, or 3.; Single dose of aprepitant 185 mg tablet in the fasted state during treatment period 1, 2, or 3.; Single dose of fosaprepitant 150 mg intravenous infusion in the fasted state during treatment period 1,2, or 3.; Single dose of aprepitant 165 mg or 185 mg tablet in the fed state during treatment period 4.
Intervention MeSH terms: Aprepitant; Fosaprepitant
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Set Point Acupuncture for Migraines Using a Digital Assistant
Condition: Migraine Headaches
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 1

Summary: 
      The object of this research study is to test a standardized set of acupuncture points on
      migraine patients to reduce frequency and intensity of headaches. Acupuncture has been
      studied in prior research but the treatment points have varied between subjects, making it
      difficult to replicate studies.
    

Detailed description: 
      Subjects will be recording daily headache activity on personal digital assistants (PDA's) for
      12 weeks before and 12 weeks after 8 weeks of acupuncture intervention. MIDAS, HIT-6 and
      BDI-II measurements will be done at the beginning of the study (12 weeks pre-intervention),
      directly before the intervention, directly after, and 12 weeks post-intervention.
      Measurements will be compared before and after intervention. This is a follow-up to a
      successful earlier study when these same acupuncture points were used on subjects with
      chronic daily headache, the majority being migraine.
    

Intervention name(s): acupuncture
Intervention type(s): Procedure
Intervention description(s): 8 weeks of acupuncture, starting with twice a week for 4 weeks, followed by once a week for 4 weeks, using 8 standardized, bilateral acupuncture points.
Other intervention name(s): Migraines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: migraine; headache; acupuncture
Eprotirome for the Treatment of Dyslipidemia, Efficacy and Safety 12-Week, Phase ii Study to Assess the Safety and Efficacy of KB2115 in Patients With Primary Hypercholesterolemia
Condition: Primary Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Eprotirome (KB2115) is a liver selective thyroid hormone that can induce hyperthyroidism in
      the liver, while an euthyroid state is preserved in the extrahepatic tissue. Eprotirome has
      in a clinical 2-weeks studies demonstrated pronounced reduction of independent risk factors
      for the development of atherosclerotic cardiovascular diseases.

      The purpose of the study is to assess the efficacy and safety of KB2115 as monotherapy
      following 12 weeks of exposure compared to placebo. The aim of the study is to assess
      efficacy (LDL-cholesterol lowering effects) and safety of KB2115.
    


Intervention name(s): Eprotirome; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): KB2115
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: hypercholesterolemia; dyslipidemia; thyroid; safety
Breaking Down Barriers to Diabetes Self-Care
Condition: Type 1 Diabetes; Type 2 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      Performance of self-care recommendations is key to the successful treatment of diabetes.
      However, many patients have difficulty adhering to diabetes self-care recommendations. Recent
      results from our own studies and others have identified specific barriers to diabetes
      self-care. To evaluate the efficacy of a diabetes educator-led group intervention, the
      Breaking Down Barriers Program, that addresses barriers and therefore leads to improved
      adherence to diabetes self-care recommendations, we will randomize 222 (111 type 1 and 111
      type 2) diabetes patients to one of three conditions: 1) the Breaking Down Barriers Program,
      2) a cholesterol attention control condition, or 3) a 'usual care' control condition. We
      hypothesize that those assigned to the Breaking Down Barriers group will improve self-care
      behaviors and glycemic control more than those in the two control groups. We will follow
      study subjects for one year to determine whether their self-care behaviors and glycemic
      control improved and if the improvement was maintained over time.
    


Intervention name(s): Breaking Down Barriers
Intervention type(s): Behavioral
Intervention description(s): completed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Adherence; self-care; Behavioral intervention; Diabetes
Vaccination Coverage and Uptake in Young People Experiencing or at Risk of Homelessness
Condition: Homeless Youth
Study type: Observational

Summary: 
      This retrospective audit will investigate if young people who are homeless or at risk of
      homelessness in Melbourne were up-to-date with routine childhood and adolescent vaccines on
      first encounter with a nurse-led primary health clinic (the Young People's Health Service),
      and if they commenced and completed immunisation catch-up plans following referral to the
      Young People's Health Service immunisation nurse.

      The purpose of the proposed study is to establish baseline immunisation coverage within the
      targeted population, then to explore the impact of an immunisation nurse role on immunisation
      coverage in a population of young people aged 15-24 years who are experiencing or at risk of
      homelessness.

      The Young People's Health Service is a program of the Royal Children's Hospital Department of
      Adolescent Medicine. The data collected will be sourced solely from the Royal Children's
      Hospital Electronic Medical Records.
    


Intervention name(s): Referral to the Young People's Health Service immunisation nurse
Intervention type(s): Other
Intervention description(s): Young people who have been referred to an immunisation nurse at the Young People's Health Service.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Young people aged 15-24 years of all genders who have been referred to the Young People's
        Health Service immunisation nurse will be included. They have accessed a homeless youth
        service, refuge, or flexible learning centre in Melbourne, Australia. The study will
        include those who were referred between 19th February 2019 to 19th July 2020.
      
Keywords: homeless youth; vaccination
A Clinical Comparison of Two Daily Disposable Soft Contact Lenses
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      This double-masked, randomized, bilateral, crossover, direct refit study compared the
      clinical performance of two daily disposable contact lenses (somofilcon A and stenfilcon A)
      when fitted to existing wearers of comfilcon A monthly lenses.
    

Detailed description: 
      This double-masked (subject and investigator), randomized, bilateral, crossover, direct refit
      study compared the clinical performance of two daily disposable test contact lenses
      (somofilcon A and stenfilcon A) when fitted to existing wearers of comfilcon A monthly
      lenses. After a month of re-useable lens wear in the comfilcon A lenses, subjects were
      randomized to wear each daily disposable lens type for one week.
    

Intervention name(s): comfilcon A; somofilcon A; stenfilcon A
Intervention type(s): Device; Device; Device
Intervention description(s): Contact Lens; daily disposable contact lens; daily disposable contact lens
Other intervention name(s): Control Lens; somofilcon A daily disposable test lens; Test lens 1; stenfilcon A daily disposable test lens; Test lens 2
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Impact of Endometriosis on Pregnancy and Delivery - a Retrospective Cohort Study
Condition: Endometriosis; Pregnancy Complications; Delivery Complication; Complication; Miscarriage
MeSH terms: Endometriosis; Abortion, Spontaneous; Pregnancy Complications
Study type: Observational

Summary: 
      Purpose:

      To study the impact of endometriosis on subsequent pregnancy and delivery.

      Methods:

      retrospective analysis by questionnaire / interview of cases (endometriosis laparoscopically
      removed / child wish) vs. controls (endometriosis laparoscopically excluded / child wish)
      from the University Hospital Muenster, Germany, treated between 2009 and 2016; analysis of
      pregnancy rate, mode of delivery and complications using Clavien-Dindo-classification, role
      of deep infiltrating endometriosis using ENZIAN classification; data analysis using t-test
      with p < 0.050% being considered significant.
    


Intervention name(s): questionnaire
Intervention type(s): Other
Intervention description(s): if no Reply to questionnaire, telephone interview
Other intervention name(s): interview
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        cases (endometriosis laparoscopically removed / child wish) vs. controls (endometriosis
        laparoscopically excluded / child wish) from the University Hospital Muenster, Germany,
        treated between 2009 and 2016
      
Keywords: endometriosis; pregnancy; delivery; miscarriage; cesarian section
Comparison of Two Different Heart-lung Machine Filling Methods: Precoating Versus Colloidal Fluids
Condition: Priming; Cardiac Surgery; Cardio Pulmonary Bypass
Study type: Interventional

Summary: 
      The study is a single-center, randomized, un-blinded treatment study in which patients (>78
      years) with the use off a heart-lung machine were provided into two study arms.

      Patient wit "precoating" have a filling of the machine with their own blood. In the
      comparator arm, a standard priming is used.
    


Intervention name(s): Precoating; Standard priming
Intervention type(s): Procedure; Procedure
Intervention description(s): preoperative filling of heart lung machine with patients blood; preoperative filling of heart lung machine with colloids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: priming; cardiac surgery; cardio pulmonary bypass; precoating
PAC-IC-SAS Pilot Study - Central Sleep Apneas Syndrome and Ventricular Function
Condition: Central Sleep Apneas Syndrome; Heart Failure; Coronary Artery Bypass Graft Surgery or Other Coronary Reperfusion
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Central; Heart Failure; Syndrome
Study type: Interventional

Summary: 
      The aim of this clinical trial is to evaluate the effect of an early treatment of
      sleep-disordered breathing by adaptive servo-ventilation in heart failure patient following
      coronary artery bypass graft surgery or other coronary reperfusion.
    

Detailed description: 
      This clinical trial is a pilot study, on patients with central sleep apneas syndrome and
      heart failure, undergoing coronary artery bypass graft surgery or other coronary reperfusion,
      and then randomized for the adaptive servo-ventilation treatment application or not after
      surgery.

      The first objective is to evaluate the effect of an early treatment of sleep-disordered
      breathing by adaptive servo-ventilation in heart failure patient, in terms of ventricular
      recovery (ejection fraction improvement). This treatment will be instaurated just after
      coronary artery bypass graft surgery or other coronary reperfusion.

      Secondary objectives :

        -  Assessment of adaptive servo-ventilation effect on the endothelial function, the
           systemic inflammation and oxidative stress, the insulin resistance, after the surgery in
           comparison with non treated patient with heart failure and central sleep apneas.

        -  Assessment of the impact of nocturnal desaturation level on the vascular reactivity and
           atherosclerosis of mammary vessels collected only during coronary artery bypass graft
           surgery.

        -  Assessment of the impact of nocturnal desaturation level on the oxidative stress,
           inflammation and insulin sensitivity on abdominal and epicardiac adipose tissue
           collected during surgery.
    

Intervention name(s): Adaptive servo-ventilation post-operative treatment for 6 months
Intervention type(s): Procedure
Other intervention name(s): Adaptive servo-ventilation for sleep-disorderd breathing for 6 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: central sleep apneas syndrome; heart failure; all coronary reperfusions; adaptive servo-ventilation treatment
Study to Assess in Home Use of Evolocumab (AMG 145) Administration Using Either an Automated Mini-doser or a Prefilled Autoinjector/Pen
Condition: Primary Hypercholesterolemia; Mixed Dyslipidemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study was to assess users' ability to administer a full dose of
      evolocumab in a home-use setting using either an automated mini-doser (AMD) or
      autoinjector/pen (AI/pen).
    


Intervention name(s): Evolocumab AMD; Evolocumab AI/pen
Intervention type(s): Biological; Biological
Intervention description(s): Evolocumab subcutaneous injection using a single use, disposable AMD containing 3.5 mL deliverable volume.; Evolocumab subcutaneous injection using a handheld mechanical (spring-based) prefilled AI/Pen, each containing 1.0 mL deliverable volume.
Other intervention name(s): AMG 145; Repatha; AMG-145; Repatha
Intervention MeSH terms: Evolocumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LDL-C, triglycerides, high cholesterol
Tolerability/Safety of Intranasal AZD8848 in Healthy Male Volunteers and Seasonal Allergic Rhinitis Male Patients Out of Season
Condition: Healthy; Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 1

Summary: 
      Investigate safety/tolerability after a single dose intranasal administration of AZD8848
      comparator placebo to healthy male volunteers and seasonal allergic rhinitis male patients
      out of season
    


Intervention name(s): AZD8848; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Concentrate for nasal spray,solution 60 mg/g
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy male; allergic rhinitis; tolerability; safety; intranasally; Healthy subjects
Opioid Free Anesthesia in Thoracic Surgery
Condition: Thoracic Surgery; Analgesics, Opioid; Anesthesia, Conduction
MeSH terms: Aortic Dissection
Study type: Interventional

Summary: 
      Proper assessment of pain and adequate analgesia in thoracic surgery is a challenging issue
      for medical practitioners. Basic aspects of thoracic anaesthesia are general anesthesia,
      intubation with double lumen tube and separation of lung ventilation, however proper
      analgesia needs to be standardized. Role of opioids in this clinical setting is reduced due
      to high risk of respiratory system complications. Instead, use of opioid free anaesthesia and
      regional anaesthesia is proposed. The aim of this study is to compare the use of opioid
      anaesthesia with opioid free anaesthesia and paravertebral block.
    


Intervention name(s): Opioid Anesthesia; Opioid Free Anaesthesia
Intervention type(s): Drug; Drug
Intervention description(s): Intraoperatively, fentanyl in fractional doses of 1-3 µg∙kg-1 were applied if the heart rate (HR; Heart Rate) or mean blood pressure (MBP; Mean Blood Pressure) increased by more than 20% above the baseline value obtained just before surgery commencement.; Before the induction of general anesthesia, a single-shot thoracic paravertebral block (ThPVB) was performed at the Th3-Th4 level. An insulated needle was used, connected to a peripheral nerve stimulator. 0.5% bupivacaine (0.3 ml∙kg-1) was then injected after a negative aspiration test. The efficacy of the blockade was checked after 20 min on both sides of the thorax with a plastic ampoule of saline. A difference in the sensation of cold between the sides of the thorax was assumed to indicate an effective block. Afterwards a continuous intravenous infusion of lidocaine and ketamine was started:
immediately after anesthesia induction, lidocaine was administered as an i.v. bolus at a dose of 1.5 mg∙kg-1 and ketamine in an i.v. bolus of 0.35 mg∙kg-1;
followed by an infusion of lidocaine 2.0 mg∙kg-1∙h-1 for 2 hours, continued at a dose of 1.2 mg∙kg-1∙h-1, and ketamine infusion 0.2 mg∙kg-1∙h-1 for 2 hours, continued at a dose of 0.12 mg∙kg-1∙h-1.
Intervention MeSH terms: Analgesics, Opioid; Anesthetics
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effect of Tiotropium + Olodaterol on Breathlessness in COPD Patients
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive; Dyspnea
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of the present study is to evaluate the effect of tiotropium +
      olodaterol fixed dose combination (FDC) compared to tiotropium monotherapy on the intensity
      of breathlessness during the 3min constant speed shuttle test (CSST).

      A secondary objective is to explore the relationship between reductions in breathlessness
      during the 3min CSST and reductions in breathlessness during activities of everyday living as
      measured by the dyspnea domain of the Chronic Respiratory Questionnaire (CRQ) following
      bronchodilator therapy.
    


Intervention name(s): Tiotropium; Olodaterol; Tiotropium
Intervention type(s): Drug; Drug; Drug
Intervention description(s): fixed dose combination once daily; fixed dose combination once daily
Intervention MeSH terms: Tiotropium Bromide; Olodaterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparing Efficacy of PRP Combined With Different Hyaluronan for the Treatment of Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Either PRP or HA is each effective for treating knee OA. However, the efficacy of combined
      PRP and HA injections remains unknown clinically.
    

Detailed description: 
      Intraarticular plasma-rich platelet (PRP) or hyaluronic acid (HA) was each effective for knee
      osteoarthritis(OA). The efficacy of combined injections remains unknown. This study aimed to
      evaluate the efficacy of PRP combined with different hyaluronan for treating knee OA. In a
      prospective, randomized-controlled trial, 95 patients with Kellgren-Lawrence grade 2 knee OA
      were randomized to receive a single intraarticular Artz (10mg/ml) followed by PRP (N=48) into
      target knee or single HYAJOINT Plus (20mg/ml) injection followed by PRP (N=47). Primary
      outcome was the change from baseline in the visual analog scale (VAS) pain at 6 months.
      Secondary outcomes included the Western Ontario and McMaster Universities Osteoarthritis
      Index (WOMAC), Lequesne index, single leg stance test (SLS), use of rescue analgesics and
      patient satisfaction.
    

Intervention name(s): PRP+Artz group; PRP+ HYAJOINT Plus group
Intervention type(s): Combination Product; Combination Product
Intervention description(s): The patients in the PRP+Artz group received one intraarticular Artz injection (2.5 ml) followed consecutively by one intraarticular injection of PRP (3ml).; The patients in the PRP+HYAJOINT Plus group received one intraarticular HYAJOINT Plus injection (3ml) followed by one intraarticular injection of PRP (3ml).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The purpose of this study was to compare the efficacy of a single Artz injection followed by PRP with a single HYAJOINT Plus injection followed by PRP in the management of knee OA.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hyaluronic acid; Knee; Osteoarthritis; Platelet-rich plasma
Study Evaluating PRA-027 Multiple Ascending Doses In Cycling And Postmenopausal Women
Condition: Uterine Leiomyomata (Fibroids)
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is the first multiple-dose study in humans with PRA-027. This study will provide an
      assessment of the safety, tolerability, pharmacokinetics (how the drug is absorbed,
      metabolized and excreted by the body) and pharmacodynamics (a measure of whether the drug is
      active in the body) of PRA-027 after administration of 28 days of oral doses in women of
      childbearing potential (cycling) or postmenopausal women.
    


Intervention name(s): PRA-027
Intervention type(s): Drug
Intervention description(s): PRA-027 capsules; cohort-specific doses or 40, 120, 240 or 500 mg; 1 dose daily for 28 days
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment