bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Injectable Platelet-Rich Fibrin (i-PRF) in Initial Treatment of Chronic Periodontitis
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Current treatments of periodontitis have limited efficacy since they fail to suppress
      microorganisms satisfactorily over time. The aim of present study was to investigate whether
      there are differences between initial treatment of chronic periodontitis (SRP) and SRP in
      conjunction with injectable platelet-rich fibrin (i-PRF) application.
    

Detailed description: 
      Current treatments of periodontitis have limited efficacy since they fail to suppress
      microorganisms satisfactorily over time. The aim of present study was to investigate whether
      there are differences between initial treatment of chronic periodontitis (SRP) and SRP in
      conjunction with injectable platelet-rich fibrin (i-PRF) application.

      Thirty patients with chronic periodontitis who had at least two sites with perriodontal
      pocket depth (PPD) ≥ 4 mm on contralateral side will be involved in the study. Using a
      split-mouth design, patients will be treated with SRP + I-PRF -(test group) or SRP
      only-(control group). Gingival crevicular fluid (GCF) and subgingival plaque will be
      collected with paper points (DentsplyMaillefer, Tulsa, Oklahoma, USA) at baseline and 1, 3
      and 6 months after the treatment. The presence and concentrations of Aggregatibacter
      actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg), Prevotella intermedia (Pi) and
      Tannerella forsythia(Tf) will be analyzed by real-time polymerase chain reaction (qPCR).
      Periodontal parameters, including bleeding on probing (BOP), probing pocket depth (PPD) and
      the clinical attachment level (CAL), will be recorded on both sides, as well as concentration
      of TNF-alpha (tumor necrosis factor alpha), ALP(alkaline phosphatase) and MMP-8
      (matrix-metalloproteinase-8).
    

Intervention name(s): SRP + Injectable Platelet-Rich Fibrin; SRP + placebo
Intervention type(s): Drug; Drug
Intervention description(s): Injectable Platelet-Rich Fibrin application as adjunct to scaling and root planing; Saline application during scaling and root planing
Other intervention name(s): SRP + i-PRF; SRP + saline
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: split mouth design
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: periodontitis; therapy; Platelet; Rich; Fibrin; Nonsurgical
A Pilot Study of Additional Chinese Formula for Concurrent Chemoradiotherapy in Oral Cavity Cancer Patients
Condition: Head and Neck Neoplasm; Chemoradiotherapy
MeSH terms: Head and Neck Neoplasms; Mouth Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this clinical trial is to learn about the clinical efficacy of
      San-Zhong-Kui-Jian-Tang (SZKJT), a formula of Chinese medicine in head and neck cancer
      patients receiving concurrent chemoradiotherapy (CCRT) treatments. The main questions it aims
      to answer are:

        -  Can SZKJT improve the completion rate of CCRT?

        -  Can SZKJT reduce the adverse effects of CCRT?

        -  How SZKJT affect the quality of life in the patients receiving CCRT

        -  How about the safety of using SZKJT in the patients receiving CCRT

      Participants will be asked to:

        -  take SZKJT for 9 weeks during the whole CCRT course

        -  take questionnaires of quality of life
    

Detailed description: 
      San-Zhong-Kui-Jian-Tang (SZKJT) is originated from the Secret Treasure of the Orchid Chamber
      written by Gao Li (AC1180 - 1251). SZKJT contains 16 herbs to treat abnormal swelling or
      nodules. In the theory of Chinese medicine, SZKJT can clear heat and resolve toxin, which
      leads to disperse swelling and binds in nodules.

      The purpose of this study is to explore the clinical efficacy and safety of SZKJT in
      improving the completion rate of concurrent chemoradiotherapy (CCRT) in patients with head
      and neck cancer, and to evaluate the prevention and treatment effects of SZKJT on the side
      effects of chemoradiotherapy, as well as the improvement of quality of life.

      The primary endpoint of the study is the completion rate of CCRT under SZKJT treatment. The
      secondary endpoints are adverse effects of CTCAE, body constitution questionnaire (BCQ) and
      the EORTC core quality of life questionnaire (QLQ-C30). Liver and kidney functions are
      considered as well for adverse effects of SZKJT. We hypothesized that additional SZKJT with
      CCRT might improve completion rate of CCRT and reduce severity of adverse effects of CCRT.
    

Intervention name(s): SZKJT(San-Zhong-Kui-Jian-Tang)
Intervention type(s): Drug
Intervention description(s): The SZKJT samples were made and packed by Kaiser Pharmaceutical Co. Ltd. with lot number of 2019023247.
Other intervention name(s): Product from Kaiser Pharmaceutical Co. Ltd.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Head and Neck Neoplasms;; Chemoradiotherapy; Complementary Therapies; Medicine, Chinese Traditional
Riociguat Clinical Effects Studied in Patients With Insufficient Treatment Response to Phosphodiesterase-5 Inhibitor
Condition: Hypertension, Pulmonary
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      BAY63-2521 Riociguat leads to the relaxation of smooth muscle cells in pulmonary arteria and
      may also inhibit abnormal remodeling of lung blood vessels. In patients with pulmonary
      arterial hypertension Riociguat showed to reduce the pulmonary blood pressure and improved
      the right heart function without unacceptable side effects. Here dose of Riociguat will be
      adjusted over 8 weeks then a Maintenance Phase of 16 weeks follows. Patients with Pulmonary
      Arterial Hypertension treated with stable doses of Phosphodiesterase Type-5 Inhibitors (Eg
      Sildenafil, Tadalafil) not appropriately responding to therapy will be included. Based on
      previous evidence and on the different modes of action an improvement of exercise capacity,
      heart function and quality of life may be expected if PDE5i treatment is transitioned to
      riociguat.

      Where Riociguat is pending market approval or reimbursement once the treatment phase is
      completed drug can be made available for another 18 months (Extended Drug Supply Phase -
      EDSP) under study conditions. Patients may also transition at the end of the maintenance
      period or any time during the EDSP to any program that is intended to provide riociguat until
      drug approval/reimbursement, e.g. a long-term extension study, compassionate use or named
      patient program. Study termination is also possible at any time.
    


Intervention name(s): Riociguat (Adempas, BAY63-2521)
Intervention type(s): Drug
Intervention description(s): Riociguat / BAY63-2521 film-coated tablets will be used in this study at a dosage of either 0.5, 1.0, 1.5, 2.0, and 2.5 mg. 3 times daily
Intervention MeSH terms: Riociguat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma
Condition: Uncontrolled Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3
      Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with
      Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist
    

Detailed description: 
      This is a randomized, double-blind, parallel group, placebo-controlled study designed to
      evaluate efficacy and safety of tralokinumab administered subcutaneously in subjects with
      uncontrolled asthma on inhaled corticosteroid plus long-acting β2-agonist and having a
      history of asthma exacerbations. Approximately 770 subjects will be randomized globally.
      Subjects will receive tralokinumab, or placebo, administered via subcutaneous injection at
      the study site, over a 52-week treatment period.
    

Intervention name(s): Experimental: Tralokinumab; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Tralokinumab subcutaneous injection; Placebo subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Cognitive-driven ADL Impairment as a Predictor for PDD
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      Mild cognitive impairment in Parkinson's disease (PD-MCI) is the highest risk factor for
      Parkinson's disease dementia (PDD). The core feature for differentiating PDD from PD-MCI is
      the loss of the ability to perform activities of daily living (ADL). As Parkinson's Disease
      (PD) is primarily a movement disorder, the distinction between motor and cognitive
      contributions to ADL in PD is an obvious challenge, which the investigators aimed to explore
      in this study. The goal of the study is to evaluate whether PD-MCI patients with more
      pronounced, cognitive-driven ADL impairment are at higher risk for cognitive worsening and
      PDD. A longitudinal follow-up assessment of 262 non-demented PD patients will be conducted
      over the next two years, with a comprehensive clinical assessment as well as biomarker
      sampling (cerebrospinal fluid and blood markers). Primary longitudinal outcome will be
      conversion to PDD and PD-MCI. Conversion rates of patients with and without additional mild
      cognitive-driven ADL impairment at baseline will be compared. Novel scores of the Pfeffer
      Functional Activities Questionnaire (FAQ) are used to assess instrumental ADL,
      differentiating between cognitive- and motor-driven ADL impairment in PD-MCI.
    


Intervention name(s): Functional Activities Questionnaire
Intervention type(s): Diagnostic Test
Intervention description(s): The FAQ is an economic and easy to apply activity of daily living scale. We aim to validate the prognostic value of novel FAQ scores, which differentiate cognitive- from motor-driven activity of daily living function.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants of the already recruited ABC-PD (Amyloid-Beta in cerebrospinal fluid as a risk
        factor for cognitive dysfunction in Parkinson's Disease) cross-sectional cohort (Ethic
        Protocol of the Medical Faculty Tuebingen 686/2013B01) will be asked to participate in the
        follow-up assessment. A drop-out rate of 20% is expected for follow-up retention.
        Therefore, investigation of 209 patients will be conducted between August 2018 and April
        2020.
      
Biospecimen description: 
      Through venipuncture, the following samples will be taken:

        -  venous blood for the determination of routine values (1 Serum tube)

        -  venous blood for RNA Isolation

        -  venous blood for DNA isolation

        -  venous blood in 1 Serum tube

      A lumbar puncture at level L3/L4 or L4/L5 of the spine will be performed by a qualified
      clinician in subsample of the cohort. Neurodegenerative markers such as Abeta1-42 and
      Abeta1-40 will be analysed.
    
Keywords: Activity of daily living function; Cognitive impairment; Parkinson's disease dementia
Food Effect, Oral & Intravenous Pharmacokinetics and Absolute Bioavailability of BAY1834845 Including Drug-drug Interaction With Methotrexate
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is planned to explore the effect of food on the oral pharmacokinetics, the
      intravenous pharmacokinetics and the absolute bioavailability of BAY1834845. Furthermore,
      this study will investigate the effect of BAY1834845 on the pharmacokinetics of orally
      administered methotrexate in healthy male subjects.
    


Intervention name(s): BAY1834845; BAY1834845; Methotrexate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single oral dose (IR [immediate release] tablets); I.v. infusion of [13C6]-labeled BAY1834845; Single dose of commercially available MTX
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study to Investigate Effect of Clarithromycin, a Strong CYP3A4 Inhibitor, on Brensocatib Pharmacokinetics in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to determine the effect of clarithromycin on the
      single-dose pharmacokinetics (PK) of brensocatib in healthy participants.
    


Intervention name(s): Brensocatib; Clarithromycin
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablets.; Oral tablets.
Other intervention name(s): INS1007
Intervention MeSH terms: Clarithromycin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Influence of Education on Acceptance of Treatment for Attention Deficit Hyperactivity Disorder (ADHD) Among Women
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      The goal of this research study is to measure what percentage of women who suspect they have
      symptoms of ADHD will go on to be diagnosed with ADHD using accepted practice standards. The
      study will also evaluate the influence education on the genetics of ADHD has on a woman in
      her deciding to receive behavioral health treatment for ADHD.
    

Detailed description: 
      Attention Deficit Hyperactivity Disorder (ADHD) affects approximately 10-12% of school-aged
      children in the United States, making it one of the most common psychiatric disorders in
      children. It is characterized as inattention and hyperactivity-impulsivity, which has
      persisted for at least 6 months to a degree that is maladaptive and inconsistent with
      developmental level (DSM-IV-TR). ADHD is a non-fluctuating illness unlike many other
      psychiatric co-morbid conditions.
    

Intervention name(s): Education
Intervention type(s): Behavioral
Intervention description(s): Education on the genetics of ADHD and treatment options for ADHD
Other intervention name(s): Attention Deficit Hyperactivity Disorder; Hyperactivity Disorder; Attention Deficit Disorder; Mental Health
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women in and around the Sioux Falls area.
      
Biospecimen description: 
      saliva
Analysis of the Pharmaceutical Validation of Picc Line Installation Requests at the Nîmes University Hospital
Condition: Parenteral Nutrition
Study type: Observational

Summary: 
      The picc line is a central venous catheter inserted peripherally into a deep vein in the arm
      (cephalic, basilic or axillary) whose distal end is located at the junction of the superior
      vena cava / atrium.

      It is installed for a minimum of 7 days (1), and can be stored for up to 6 months or more if
      it is functional. For treatments with an indication of more than 3 months, it is common
      practice to place an implantable catheter chamber. The main indications for picc line
      placement are: long-term antibiotic therapy, parenteral nutrition, chemotherapy or long-term
      venous approach when difficulties are encountered in applying a peripheral venous route to
      the patient.

      Quickly adopted by medical teams, picc lines are not without risk, however, and three
      complications are mainly reported: catheter obstruction, deep vein thrombosis and infections.

      In order to avoid any risk of unnecessary complications, it therefore seems appropriate to
      target the most appropriate device upstream of the procedure according to the provisional
      indication.

      An inventory of pharmaceutical interventions carried out during picc line requests would make
      it possible to lay the foundations for considering actions to be implemented with the various
      services requesting picc line and proposals for improvement for the follow-up of patients
      with picc line to reduce the risk of complications.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The patients included in the study are patients aged at least 18 years old, hospitalized at
        the University Hospital of Nîmes and benefit from a pharmaceutical validation of the
        connected request for picc line in the Xplore® software.
Assessment of Cholinergic and Cognitive Function Using Pharmacologic ASL-Perfusion MRI
Condition: Cholinergic Function
Study type: Interventional

Summary: 
      This research study will look at how medications affect the pattern of blood flow in the
      brain. This study will use a special type of MRI (magnetic resonance imaging) scan called
      perfusion MRI to make measurements of cerebral (brain) blood flow. The medications we will
      use in this study are scopolamine (commonly used to treat motion sickness), mecamylamine
      (used to treat high blood pressure), and donepezil (used to treat memory loss). Cognitive
      testing will also be obtained, and correlated with the blood flow patterns in the brain.
    

Detailed description: 
      Project Summary: This research project will investigate the value of combined pharmacologic
      manipulation and arterial spin-labeled perfusion MRI (pharmacologic ASL-pMRI) as an in vivo
      probe of cholinergic function. Methods to investigate cholinergic function in vivo are needed
      to better understand the role of acetylcholine in the physiology of the cerebral cortex, and
      in cognitive processes in health and in disease states. In this study, pharmacologic ASL-pMRI
      will be used to characterize the normal cerebral perfusion response to cholinergic
      manipulation in young healthy subjects. Cognitive measures will also be obtained and
      correlated with cerebral perfusion changes. Pharmacologic ASL-pMRI and cognitive testing will
      then be used to study how the cholinergic response is altered with normal aging and in
      delirium
    

Intervention name(s): Scopolamine; Placebo; Donepezil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Scopolamine 0.4mg IM x 1 dose; adjustment in older group for weight (0.4mg/70kg); IM or PO placebo; donepezil 5mg PO x 1
Other intervention name(s): Aricept
Intervention MeSH terms: Scopolamine; Donepezil; Butylscopolammonium Bromide
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Keywords: cholinergic function; aging; pharmacologic MRI
Bioequivalence Study in Healthy Subjects, 2*5 mg Tablets Rivaroxaban Versus 1*10 mg Tablet Rivaroxaban
Condition: Therapeutic Equivalency
Study type: Interventional
Phase: Phase 1

Summary: 
      The drug investigated in this study is Rivaroxaban, a novel, once-daily, oral anticoagulant
      for the prevention (prophylaxis) of deep vein thrombosis (DVT) which may lead to a pulmonary
      embolism (PE) in people undergoing knee or hip replacement surgery.

      The purpose of this study is to establish bioequivalence of 2 immediate-release tablet
      treatments with Rivaroxaban: 2*5 mg tablets and 1*10 mg tablet will be given to healthy
      volunteers under fasting conditions; they will be administered as single oral doses in 2
      periods. Both periods will be separated by a 7-day washout phase. Thus, the bioequivalence
      represents the primary study objective. As a secondary objective, this treatment will be
      assessed in terms of safety and tolerability.

      Bioequivalence will be evaluated and verified on the basis of pharmacokinetic data. Blood
      samples of the volunteers will be taken at specific points in time; these samples will be
      analyzed using various statistical methods to establish pharmacokinetic characteristics
      required to compare the 2 treatments. The planned treatments with Rivaroxaban will be
      considered bioequivalent if specific criteria defined in the study protocol are met.

      The study will be conducted in one center in Germany. 28 subjects meeting the inclusion
      criteria will participate. They will be treated according to a single-dose, randomized, 2-way
      cross-over, non-placebo-controlled design.
    


Intervention name(s): Rivaroxaban (Xarelto, BAY59-7939); Rivaroxaban (Xarelto, BAY59-7939)
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose of rivaroxaban administered under fasting conditions 2*5 mg tablet in first intervention period and 1*10 mg tablet in second intervention period (after washout period); Single oral dose of rivaroxaban administered under fasting conditions 1*10 mg tablet in first intervention period and 2*5 mg tablet in second intervention period (after washout period)
Intervention MeSH terms: Rivaroxaban
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence