bioihbjkbjnl/mcl2 huggingface dataset:
The Immune Response After Periodontal Treatment
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases
Study type: Interventional

Summary: 
      Primary Objective:

      To identify changes in systemic markers of inflammation following periodontal treatment,
      comparing two standard treatment modalities (hands scaling and ultrasonic scaling)

      Secondary Objectives:

      To investigate bacteraemia, composition and function of oral bacteria, treatment outcomes
      following periodontal treatment, patient and operator preferences, and treatment time
      comparing hand scaling and ultrasonic scaling.
    

Detailed description: 
      Effective root surface debridement (RSD) is essential for successful periodontal treatment.
      Myriad studies demonstrate that RSD may be carried out using hand or ulstrasonic instruments
      with equal efficacy. Locally, effective debridement results in reduced inflammation in the
      gingival tissues, ultimately preserving the dentition. Systemically, RSD results in an
      immediate inflammatory response with elevated C-reactive protein (CRP), and cytokines (e.g.
      interleukin-6 and Tumor Necrosis Factor) detectable in the serum. This systemic inflammation
      may relate to systemic dissemination of bacteria from the periodontal pockets into the
      circulation, during instrumentation. Bacteria are detectable in serum immediately after
      instrumentation. The incidence of the bacteraemia varies considerably between different
      studies, ranging from 13% of patients to 43% to 55%. These studies used different methods of
      instrumentation; Kinane et al used full mouth ultrasonic scale, Zhang et al used a mixture of
      hand and ultrasonic instruments, and Heimdahl et al used curettes only. Whilst tempting to
      speculate that ultrasonic instrumentation induces less bacteraemia than hand instrumentation,
      there is no direct comparison of the effect of ultrasonic instrumentation with hand
      instrumentation on post treatment systemic inflammation.
    

Intervention name(s): Hand Instrumentation Treatment; Ultrasonic Instrumentation Treatment
Intervention type(s): Device; Device
Intervention description(s): Provision of treatment for periodontal disease using hand instrumentation. Following this, data will be collected relating to various factors, principle of which being systemic immune response.; Provision of treatment for periodontal disease using ultrasonic instrumentation. Following this, data will be collected relating to various factors, principle of which being systemic immune response.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Analysis: the effect of treatment group (Manual vs ultrasonic) on changes in CRP levels (and other secondary outcomes):
Appropriate generalised linear models
Binary logistic models (for dichotomous outcomes)
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Root Surface Debridement; Hand Instrumentation; Ultrasonic Instrumentation; Systemic; Immune; CRP
CDC HIV Testing Guidelines: Unresolved Ethical Concerns
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      Advocacy groups have voiced concerns about the ethics of some of tenets of the CDC's new HIV
      testing recommendations for the healthcare setting. Three concerns are paramount: (1) the
      opt-out approach to HIV testing can potentially be coercive and not truly voluntary; (2) by
      replacing informed consent with general consent for medical care, test participants might not
      know or be adequately informed of the benefits and consequences of testing; and (3)
      eliminating HIV prevention counseling from the HIV testing process presumes that test
      participants are aware of how to prevent an HIV infection, which might not be correct. This
      study involves conducting interviews of HIV advocates who are raising these concerns,
      surveying outpatient and emergency department clinical providers about their beliefs and
      opinions regarding the tenets of the new guidelines, and then conducting a multi-center,
      randomized, controlled trial in which the ethical concerns of opt-out vs. opt-in testing are
      directly compared. We will conduct a multi-center, randomized, controlled, trial whereby
      patients will be surveyed on their perspectives and perceptions regarding opt-out or opt-in
      rapid HIV testing. We will survey the participants regarding their perception of coercion,
      their understanding of the elements contained in the informed consent process, their HIV risk
      factors, and their knowledge of HIV prevention. We will evaluate whether or not the
      CDC-recommended approaches regarding opt-out testing, consent, and decoupling of prevention
      counseling are supported. If there are no differences regarding these ethical concerns
      between testing approaches, then the opt-out approach would be considered not to be inferior
      to the opt-in approach.
    


Intervention name(s): CDC HIV testing recommendations
Intervention type(s): Other
Intervention description(s): Current vs. prior CDC recommendations
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: HIV testing; HIV Seronegativity
The Incidence of Extended-spectrum β-lactamase (ESBL) Klebsiella Pneumonia in Patient on Renal Replacement Therapy
Condition: End-stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Observational

Summary: 
      The prevalence of ESBL Klebsiella pneumonia was higher in patient with renal replacement
      therapy.
    


Intervention name(s): renal replacement therapy
Intervention type(s): Other
Intervention description(s): renal replacement therapy : hemodialysis and/or CRRT(continuous renal replacement therapy )
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The patients had admitted in single center
      
Keywords: end-stage renal disease; renal replacement therapy
Platelet Rich Plasma Versus Radio Frequency for Chronic Knee Arthritis
Condition: Osteo Arthritis Knee; Pain, Chronic
MeSH terms: Arthritis; Osteoarthritis; Osteoarthritis, Knee; Chronic Pain
Study type: Interventional

Summary: 
      Osteoarthritis (OA) affects aged above 45 years. RF has been used for several painful
      conditions. There have been a few attempts to use RF current for the treatment of painful
      conditions of joints of the extremities. It was also used for the treatment of painful
      conditions of the hip joint.
    


Intervention name(s): radiofrequency; platelet rich plasma injection
Intervention type(s): Procedure; Procedure
Intervention description(s): radiofrequency of the genicular nerves; intra articular injection of platelet rich plasma
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: patients with chronic knee osteoarthritis non res ponders to conventional medical treatment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Risk Management in Nursing Homes
Condition: Adverse Events Management in Nursing Homes
Study type: Observational

Summary: 
      The Réseau QualiSanté (risk management network) hardly works on risk management in nursing
      homes. A model to help nursing homes managers to structure and analyze adverse events has
      been constructed by a working group of health professionals in the Réseau QualiSanté. Several
      questions appeared: is the model able to increase patient safety culture of professionals
      working in nursing homes? How to characterize adverse events in nursing homes? How frequent
      are they? The main objective of this research project EHPAGE is to measure the impact of the
      model to structure and analyze adverse events in nursing homes on the patient safety culture
      of professionals. The project combines quantitative data (questionnaire) and qualitative data
      (interviews).
    

Detailed description: 
      The main objective of this research project EHPAGE is to measure the impact of the model to
      structure and analyze adverse events in nursing homes on the patient safety culture of
      professionals. The coaching model is composed of a 20 hours methodological help for each
      nursing home and of an implementation kit.

      To answer to the main objective, quantitative and qualitative data will be collected twice
      during the project: before the implementation of the coaching model and 12 months after.

      Secondary objectives are:

        1. To encourage the place of patient safety culture in strategic issues of nursing homes

        2. To develop patient safety culture of professionals working in nursing homes

        3. To develop a way to structure and make the reporting of adverse events in nursing homes
           more sustainable

        4. To describe epidemiologic characteristic of adverse events in nursing homes

        5. To propose a French validated questionnaire to evaluate patient safety culture reported
           by professionals in nursing homes An ancillary study is perform to describe
           epidemiologic characteristic of adverse events in nursing homes
    

Intervention name(s): Implementation of the coaching model
Intervention type(s): Other
Intervention description(s): 20 hours methodological help for each nursing home and an implementation kit
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        61 nursing home located in Loire-Atlantique and Vendée departments in France.
        Loire-Atlantique and Vendée departments already benefit the risk management model from the
        réseau qualisanté located in Nantes University Hospital
      
Keywords: risk management; nursing home; elderly; care
Personality Profiles, Values and Empathy: Differences Between Ovo/Lacto-vegetarians and Vegans
Condition: Personality
MeSH terms: Personality Disorders
Study type: Observational

Summary: 
      Main goal is to collect and analyze possible differences between ovo / lacto-vegetarians and
      vegans with respect to their personality profiles, values and empathy through validated
      questionnaires. Main hypothesis: vegans and ovo / lacto-vegetarians differ in their
      personality, empathy and values
    


Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        5000-10000 vegetarian volunteers
      
Keywords: personality profiles; values; empathy; quality of life; vegetarians; vegans
A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Under Fed Conditions
Condition: Parkinson's Disease; Restless Leg Syndrome
MeSH terms: Parkinson Disease; Restless Legs Syndrome
Study type: Interventional

Summary: 
      The objective of this study was to assess the single dose bioequivalence of Roxane's
      Ropinirole tablets,0.25 mg, to ReQuip Tablets, 0.25 mg (GlaxoSmithKline) under fed conditions
      using a single dose, randomized, 2-treatment, 2-period, 2-sequence cross-over design.
    

Detailed description: 
      The objective of this study was to assess the single dose bioequivalence of Roxane's
      Ropinirole tablets,0.25 mg, to ReQuip Tablets, 0.25 mg (GlaxoSmithKline) under fed conditions
      using a single dose, randomized, 2-treatment, 2-period, 2-sequence cross-over design.
    

Intervention name(s): Ropinirole Hydrochloride
Intervention type(s): Drug
Intervention description(s): Restless Leg Syndrome
Intervention MeSH terms: Ropinirole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pilot Study To Assess CAT-2003 in Patients With Severe Hypertriglyceridemia
Condition: Hyperlipidemias; Hypertriglyceridemia; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases
MeSH terms: Dyslipidemias; Hyperlipidemias; Metabolic Diseases; Hypertriglyceridemia; Lipid Metabolism Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and efficacy of multiple doses of
      CAT-2003 in patients with severe hypertriglyceridemia either naive or refractory to current
      therapy. The study will evaluate effects of CAT-2003 on fasting and postprandial total
      triglycerides and chylomicron triglyceride levels in patients with severe
      hypertriglyceridemia.

      This is a single-blind study. All patients will receive placebo for a 14 day treatment period
      and CAT-2003 for a 28 day treatment period.
    


Intervention name(s): CAT-2003; Placebo
Intervention type(s): Drug; Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Cognitive Stimulation in Adolescents
Condition: Substance Use Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to see if computer tasks that challenge the brain (cognitively
      stimulating tasks) can improve memory and other types of thinking in adolescents and young
      adults who are being treated for substance use problems. The study will compare the effects
      of different versions of the computer tasks.
    


Intervention name(s): Computerized tasks
Intervention type(s): Behavioral
Intervention description(s): The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Clinical Characterisation of the Vascular Effects of Cis-platinum Based Chemotherapy in Patients With Testicular Cancer
Condition: Testicular Cancer; Cardiovascular Diseases
MeSH terms: Testicular Neoplasms; Cardiovascular Diseases
Study type: Observational

Summary: 
      incidence is increasing1,2. Whilst the prognosis is very good with the vast majority of
      patients cured with orchidectomy alone, those with high risk stage one non seminomatous germ
      cell cancer (NSCGT) or metastatic disease (NSCGT or seminoma) are treated by surgery followed
      by chemotherapy. Platinum based chemotherapy is associated with long-term cardiovascular
      sequelae.

      Endothelial dysfunction is a key component of early atherogenesis and the later stages of
      obstructive atherosclerosis, plaque rupture and thrombus formation. Whilst endothelial toxic
      effects of BEP chemotherapy appear to be central in the pathophysiology of associated
      complications, abnormalities in endothelial function as assessed by measures of brachial
      artery flow-mediated dilatation (FMD) have not demonstrated a consistent effect over time.
      When assessed within ten weeks of platinum-based chemotherapy9, no change in FMD was observed
      whilst marked decreases are seen immediately following treatment11 and also one year
      following treatment12. Therefore, the time-course of endothelial vasomotor impairment remains
      incompletely defined in a single prospective cohort.
    

Detailed description: 
      There remains an unmet need to identify a preventive treatment for patients with testicular
      cancer treated with platinum based chemotherapy to diminish the substantial risk of
      subsequent cardiovascular events. A future randomised trial of statin therapy in these
      patients is under consideration and results from this pilot study will inform its design.

      Before moving towards interventional studies the proposed pilot study will enable a better
      understanding of the nature, time-course and dose-dependent effects of the mechanisms
      contributing to increased cardiovascular risk.

      Single-centre, prospective pilot study assessing the cardiovascular effects of treatment with
      orchidectomy or orchidectomy plus cisplatin based chemotherapy for testicular cancer.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Orchidectomy alone or Orchidectomy plus 1-2 cycles adjuvant cisplatin based chemotherapy or
        Orchidectomy plus 3-4 cycles cisplatin based chemotherapy
      
Biospecimen description: 
      biological blood samples will be retained without DNA
    
Keywords: cisplatin; flow mediated dilatation
Does Sourdough Fermentation Improve Iron Uptake From Whole Grain Rye Bread?
Condition: Iron Bioavailability; Anaemia
Study type: Interventional

Summary: 
      Iron deficiency anaemia is a major problem for women worldwide. Cereal foods are a major
      source of iron, but much of this is not bioavailability due to it being bound by the high
      amounts of phytate present in cereals. Destruction of phytate by the phytase enzyme can
      release iron and increase its bioavailability. In a human cell model of iron uptake,
      sourdough fermentation, which included activation of phytase, the enzyme that breaks down
      phyate, led to improved iron bioavailability. This clinical trial will attempt to demonstrate
      that this concept also works in humans
    


Intervention name(s): Whole grain rye bread; Whole grain sourdough rye bread
Intervention type(s): Other; Other
Intervention description(s): Whole grain rye bread baked without sourdough fermentation (normal yeast-based fermentation); Whole grain rye bread fermented with sourdough culture before baking
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Dry vs Wet Misoprostol for Cervical Dilation in First Trimester Abortion
Condition: Abortion Early
MeSH terms: Dilatation, Pathologic
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to verify whether the moisture of 400 µg of misoprostol pre uterine
      evacuation increases the dilatation of uterine cervix compared to dry misoprostol
    

Detailed description: 
      Misoprostol is the most widely used drug for abortion due to its low cost, stability and easy
      to use regimen. Nevertheless, there is a debate whether the administration of dry misoprostol
      has similar effects compared to wet pill. It would be necessary to undertake a clinical trial
      to evaluate which regimen (dry or wet) offers a better cervical dilation pre uterine
      evacuation. The primary objective of this study is to compare the degree of cervical
      dilatation pre-uterine evacuation in subject that received 400 µg of dry or wet misoprostol 3
      or more hours before the procedure. Secondary objective is to verify whether there is a
      correlation between vaginal pH (<5 / ≥5) and the degree of cervical dilation (≥8mm / <8mm)
      with the use of wet or dry misoprostol. Women will be randomized to one of the two groups:
      dry or wet misoprostol.
    

Intervention name(s): dry misoprostol; wet misoprostol
Intervention type(s): Drug; Drug
Intervention description(s): 400 µg of dry misoprostol will be introduced into the vaginal fornices 3 or more hours before uterine evacuation; 400 µg of wet misoprostol will be introduced into the vaginal fornices 3 or more hours before uterine evacuation
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: misoprostol; abortion
Study Evaluating Premarin and Bazedoxifene Potential Interaction
Condition: Postmenopause
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics (absorption, distribution,
      breakdown and elimination in the body) of a single dose of bazedoxifene (BZA) 20 mg tablet
      when administered together with multiple doses of Premarin (conjugated estrogens or CE) to
      healthy postmenopausal women.

      Information will also be obtained regarding the safety and tolerability of this combination
      in healthy, postmenopausal women.
    


Intervention name(s): Premarin
Intervention type(s): Drug
Intervention MeSH terms: Estrogens, Conjugated (USP)
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics of Peginterferon Alfa-2b in Participants With Moderate and Severe Renal Impairment (P05655)
Condition: Renal Insufficiency
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare the pharmacokinetics of a single dose of peginterferon alfa-2b
      (Sylatron®) in healthy participants to that in participants with moderate to severe
      impairment of kidney function.
    


Intervention name(s): PegIFN-2b (Sylatron®)
Intervention type(s): Drug
Intervention description(s): Single 4.5 μg/kg dose
Other intervention name(s): PegIntron®; Peginterferon alfa-2b; SCH 054031; MK-4031
Intervention MeSH terms: Peginterferon alfa-2b
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of Aerobic Exercise in Microvascular Endothelium Function in Patients With Cardiovascular Diseases
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Observational

Summary: 
      This study evaluates the effects of different volumes of aerobic exercise training in
      cardiovascular parameters of patients with cardiovascular diseases enrolled in a cardiac
      rehabilitation program.
    

Detailed description: 
      Aerobic exercise training is well known to improve endothelium dependent vasodilatation in
      the microcirculation. However, the impact of exercise frequency on this response in patients
      with coronary artery disease remains unclear.
    

Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): Patients included in the study will be enrolled in a cardiac rehabilitation program, in an independent manner of the study protocols.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients treated in the hospital in which the exercise will be performed.
      
Biospecimen description: 
      Blood samples for nitrite/nitrate quantification.