bioihbjkbjnl/mcl2 huggingface dataset:
Chemerin and Interleukin-6 Levels of Gingival Crevicular Fluid in Obese Individuals Following Periodontal Treatment
Condition: Obesity; Periodontitis
MeSH terms: Periodontitis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The objective in this case-control intervention study, therefore, was to explore the effect
      of nonsurgical periodontal therapy on the GCF levels of chemerin and IL-6 in patients with
      chronic periodontitis in order to determine the usefulness of chemerin as a diagnostic and
      prognostic biomarker of periodontal disease.
    

Detailed description: 
      All individuals underwent a full-mouth periodontal examination, which included probing pocket
      depth (PPD), clinical attachment level (CAL), plaque index (PI), gingival index (GI),
      bleeding on probing (BOP). BMI and WHR were used for assessing obesity. In addition, HbA1c
      and fasting plasma glucose levels were used for elimination of diabetes mellitus. Based on
      the periodontal and anthropometric measurements, individuals (n=72) were divided into four
      groups: the periodontal-healthy group (n=18), chronic periodontitis group (n=18),
      periodontal-healthy with obesity group (n=18) and chronic periodontitis with obesity group
      (n=18). Periodontitis patients received nonsurgical periodontal therapy. GCF sampling and
      clinical periodontal parameters were assessed before and 6 weeks after therapy. Chemerin and
      IL-6 levels were measured by enzyme-linked immunosorbent assay.
    

Intervention name(s): Non-surgical periodontal treatment; Gingival crevicular fluid collection
Intervention type(s): Other; Other
Intervention description(s): SRP under local anaesthesia, in a total of 2-3 clinical visits.
Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush.; GCF collection with filter paper (Periopaper) using the intracrevicular method.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chemerin; Interleukin-6; Gingival crevicular fluid
Efficacy and Safety of Roflumilast Taken in the Morning or Evening in Patients With Stable Asthma (12 to 70 y) (BY217/M2-015)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      Bronchial asthma is among the world's most prevalent diseases. Roflumilast is a novel, orally
      active, selective enzyme inhibitor (phosphodiesterase 4 inhibitor), which has shown
      effectiveness in the treatment of asthma.

      The aim of the study is to compare the effect of roflumilast on lung function, symptoms, and
      use of rescue medication in patients with stable asthma. Roflumilast will be administered
      orally either in the morning or in the evening at one dose level. The study duration consists
      of a baseline period (1 to 2 weeks) and a treatment period (6 weeks). The study will provide
      further data on safety, tolerability, and effectiveness of roflumilast.
    


Intervention name(s): Roflumilast
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Asthma; Roflumilast
AM-125 in the Treatment of Acute Peripheral Vertigo Following Neurosurgery
Condition: Vestibular Vertigo
MeSH terms: Vertigo; Dizziness
Study type: Interventional
Phase: Phase 2

Summary: 
      Treatment of vertigo after removal of a tumor of the balance and hearing nerve after
      neurosurgery, which damages or cuts the vestibular nerve (balance).

      This trial explores the efficacy and safety of AM-125 in the treatment of acute vertigo. In
      this proof of concept trial patients experiencing vertigo after neurosurgery (vestibular
      schwannoma labyrinthectomy and vestibular neurectomy) will receive AM-125 or placebo. It
      evaluates the potential of AM-125 versus placebo in reducing the symptoms of vestibular
      dysfunction and accelerating vestibular compensation following neurosurgery.
    


Intervention name(s): Intranasal Drug; Oral Tablet; Intranasal Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Intranasal administration of solution with betahistine dihydrochloride; Dosing 3 times a day; Oral dosing with tablets 3 times a day; Intranasal administration of solution without betahistine dihydrochloride; Dosing 3 times a day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vertigo; Balance
Comparative Study of the Pharmacokinetics of Rinsulin® Mix 30/70, Suspension for Subcutaneous Administration, 100 IU / ml (OJSC GEROPHARM-Bio, Russia) and Humulin® M3, Suspension for Subcutaneous Administration, 100 IU / ml (Lilly France, France) Using the Euglycemic Hyperinsulinemic Clamp Method
Condition: Bioequivalence
Study type: Interventional

Summary: 
      Pharmacokinetics and pharmacodynamics study of 2 formulations of insulin mixtures Rinsulin®
      Mix 30/70, Suspension for Subcutaneous Administration, 100 IU / ml (OJSC GEROPHARM-Bio,
      Russia) versus Humulin® M3, Suspension for Subcutaneous Administration, 100 IU / ml (Lilly
      France, France).
    

Detailed description: 
      Double-blinded, randomized, comparative, crossover study of comparative pharmacokinetics of
      Rinsulin® mix 30/70, suspension for subcutaneous administration, 100 IU / ml (OJSC
      GEROPHARM-Bio, Russia) and Humulin® M3, suspension for subcutaneous administration, 100 IU /
      ml (Lilly France, France) using hyperinsulinemic euglycemic clamp method on healthy
      volunteers.
    

Intervention name(s): Rinsulin® mix 30/70; Humulin® M3
Intervention type(s): Drug; Drug
Intervention description(s): one subcutaneous injection at a dose of 0.4 IU/kg; one subcutaneous injection at a dose of 0.4 IU/kg
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: two-period two-way crossover
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: human recombinant insulin; euglycemic hyperinsulinemic clamp
Randomized Controlled Meditation Trial for Treating OCD
Condition: OCD
Study type: Interventional

Summary: 
      The trial objective is to compare two very different meditation protocols (Kundalini Yoga and
      Relaxation Response meditation techniques) to help the OCD treatment.
    

Detailed description: 
      The proposed trial comparing the two different meditation protocols is expected to have two
      phases: 0-month to 4.5-month period where we compare the Kundalini Yoga protocol with
      Relaxation Response meditation technique, both on the primary efficacy variable using the
      Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and some if not most of the secondary
      variables using The Dimensional Yale-Brown Obsessive Compulsive Scale (DY-BOCS), Clinical
      Global Impressions (CGI), Profile of Mood States (POMS), Beck Anxiety Inventory (Beck-A),
      Beck Depression Inventory (Beck-D), and SF-36 Health Status Questionnaire (SF36).
      Participants will go to the hospital once a week for a 1,5 hour meditation class.After
      4.5-months, all patients will be evaluated and merged together into a single group. Patients
      will then receive 09 to 12 more months of the meditation protocol. The investigators are
      expecting to recruit 50 to 60 patients to start. Patients will be blinded to the content of
      the protocol in the other group at baseline and until one group shows greater efficacy on the
      primary efficacy variable. The intake physician will be blinded to the treatment groups of
      the patients.
    

Intervention name(s): Kundalini Yoga Meditation; Relaxation Response Meditation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The trial will compare two very different meditation protocols. After the 4.5 month the patients will be reevaluated, and all patients will be merged together into a single group. Patients will then receive 9 - 12 more months of the meditation protocol.; The trial will compare two very different meditation protocols. After the 4.5 month the patients will be reevaluated, and all patients will be merged together into a single group. Patients will then receive 9 - 12 more months of the meditation protocol.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: OCD; YBOCS
Quality of Life in Allergic Rhinoconjunctivitis Patients Treated With Dialyzable Leukocyte Extracts
Condition: Allergic Rhinoconjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the changes of quality of life of patients with
      allergic rhinoconjunctivitis treated with standard medications plus Dialyzable Leukocyte
      Extracts (DLE). All patients will receive DLE in combination with current guide
      lines-suggested standard medication.
    

Detailed description: 
      DLE are heterogenous mixtures of peptides under 10 kilo Daltons (kDa) obtained after
      disruption of peripheral blood leukocytes from healthy human donors. DLE have been reported
      to improve clinical response in allergies, such as asthma and atopic dermatitis.

      The therapeutic effect of DLE is related to an immune modulatory effect that changes innate
      signaling pathways, such as Toll Like Receptors, and Nuclear Factor -kappa B; production of
      cytokines might also be modified with the use of DLE, including Tumor Necrosis Factor a,
      Interleukin (IL)-6, and induction of Interferon-g secretion, driving immune response to a
      T-helper Th1 immune-regulatory response, and thus helping to reduce allergy symptoms.
    

Intervention name(s): DLE; Second generation anti histamines + Nasal corticosteroids
Intervention type(s): Biological; Other
Intervention description(s): Adjuvant treatment; Standard treatment
Other intervention name(s): Transfer Factor; Transferon
Intervention MeSH terms: Histamine; Histamine Antagonists; Histamine H1 Antagonists; Histamine H1 Antagonists, Non-Sedating
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Allergic rhinoconjunctivitis; Dialyzable Leukocyte Extracts
Single and Multiple Ascending Dose Study of TD-8236 by Inhalation
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, double-blinded, placebo controlled study. The study consists
      of 3 parts: Part A is a single ascending dose (SAD) study in healthy subjects, Part B is a
      multiple ascending dose (MAD) study in subjects with stable, mild asthma, and Part C
      (Biomarker) is a multiple dose study in subjects with stable, moderate-to-severe asthma.
    


Intervention name(s): TD-8236; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Study drug to be administered via inhaler device; Placebo to be administered via inhaler device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Single ascending dose; SAD; Multiple ascending dose; MAD; Phase 1; first-in-human; TD-8236; asthma
Single-Dose Study of MK-4250 Monotherapy in Anti-Retroviral Therapy-Naive, Human Immunodeficiency Virus (HIV)-1 Infected Participants (MK-4250-002)
Condition: HIV-1 Infection
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral
      activity of MK-4250 monotherapy in anti-retroviral therapy (ART)-naïve, HIV-1 infected
      participants. The primary hypothesis of the study is that at a dose that is sufficiently safe
      and generally well tolerated, MK-4250 has superior antiretroviral activity compared to a
      historical placebo, as measured by change from baseline in plasma HIV-1 ribonucleic acid
      (RNA) (log10 copies/mL) at 168 hours postdose.
    

Detailed description: 
      The study consists of 5 panels; Panel C (MK-4250 ≤600 mg) was removed from the study with
      Protocol Amendment 1.
    

Intervention name(s): MK-4250
Intervention type(s): Drug
Intervention description(s): MK-4250 tablets for oral administration
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Crossover Bioequivalence Study of Quetiapine Fumarate 300 mg Tablets Under Steady State Fasted Conditions
Condition: Bipolar I Disorder
Study type: Interventional

Summary: 
      The objective of this study was to prove the bioequivalence of Roxane Laboratories'
      Quetiapine Fumarate 300 mg Tablet under fasted steady state conditions.
    


Intervention name(s): Quetiapine Fumarate
Intervention type(s): Drug
Intervention description(s): 300 mg tablet
Other intervention name(s): Seroquel
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mailed FIT Outreach to Improve Colon Cancer Screening in the Safety-net System
Condition: Colonic Neoplasms
MeSH terms: Colonic Neoplasms
Study type: Interventional

Summary: 
      Uptake of colorectal cancer (CRC) screening is suboptimal in the San Francisco Health Network
      and access to care may be limited so novel models of health care delivery are warranted. The
      objective of this study is to examine whether a centralized panel management model with
      mailed fecal immunochemical test (FIT) will be effective at increasing the uptake of CRC
      screening and could be developed and sustained within the typical parameters of
      cost-effectiveness and budget impact analyses.
    

Detailed description: 
      Rationale: Since uptake of colorectal cancer (CRC) screening is suboptimal in the SF
      safety-net system and access to care may be limited, novel models of health care delivery are
      warranted. The overall hypothesis is that a centralized panel management model with mailed
      fecal immunochemical test (FIT) will be effective at increasing the uptake of CRC screening
      and could be developed and sustained within the typical parameters of cost-effectiveness and
      budget impact analyses. Barriers to immunization of adults include missed opportunities
      during visits, limited access to providers, and provider and patient beliefs of efficacy.

      Design: To rigorously examine the benefit of the centralized panel management to improve
      uptake of CRC screening with mailed FIT, the electronic health system will be used to
      identify eligible patients who are not up-to-date with CRC screening. Broadly, patients will
      be randomized 1:1 to usual care or intervention arm, stratified by clinic, gender, prior
      screening, and race to receive mailed FIT kits + usual care versus usual care alone. The
      cost-effectiveness of no screening, usual care, and centralized management with mailed FIT
      outreach will be compared using mathematical simulation models.
    

Intervention name(s): FIT Outreach
Intervention type(s): Behavioral
Intervention description(s): This arm will consist of priming patients with a postcard and a possibly a phone call two weeks prior to them being mailed a FIT kit. The FIT kits will be mailed to the patients with a letter from their clinic's care team informing them why they should complete the FIT and wordless instructions to help them complete the FIT. Two weeks after the FIT kit is mailed the patients that have not returned the kit will receive up to two reminder calls. During the phone calls the outreach workers will use health coaching techniques to encourage patients to complete the FIT. All written materials have been translated into English and Chinese and during phone calls patients will be spoken to in the language that they are most comfortable using.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Moxibustion for Mild and Moderate Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether moxibustion is effective to mild and
      moderate ulcerative colitis and the effect of moxibustion on metabolism.
    


Intervention name(s): herb-partitioned moxibustion; bran-partitioned moxibustion
Intervention type(s): Other; Other
Intervention description(s): Ignited moxa cones are placed upon herbal cake. Herbs are smashed into powder. Every 2.8g medicine powder mix with 3g millet wine and then be pressed into herbal cakes which are 28mm in diameter and 7mm in high with a specific mould. Then the herbal cake with a moxa cone will be fixed on Tianshu and Shangjuxu.; Ignited moxa cones are placed upon bran cake. Every 2.8g bran powder mix with 3g millet wine and then be pressed into bran cakes which are 28mm in diameter and 7mm in high with a specific mould. Then the bran cake with a moxa cone will be fixed on Tianshu and Shangjuxu.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
A Trial to Assess the Pharmacokinetic Profile (e.g., Uptake, Distribution and Excretion of a Substance in the Body) of Nomegestrol Acetate (NOMAC), Estradiol (E2) and Estrone (E1) After Multiple and Single Dose Administration of the Combined Oral Contraception NOMAC-E2 (COMPLETED)(P05822)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this trial is to assess the pharmacokinetic profile of NOMAC, E2 and
      E1 after multiple and single dose administration of the combined oral contraceptive NOMAC-E2
    

Detailed description: 
      This trial was designed to assess the pharmacokinetic profile of NOMAC, E2 and E1 after
      multiple dose (MD) and single dose (SD) administration of NOMAC-E2 in healthy female
      volunteers.

      In total 25 subjects were to enter the trial. These subjects were synchronized for menstrual
      cycle by taking 1 tablet NOMAC-E2 (2.5 mg / 1.5 mg) daily for a minimum of 2 weeks. This was
      followed by a 7-day pill-free interval. After this, all subjects were to be exposed to the
      open-label MD treatment with 1 tablet NOMAC-E2 (2.5 mg / 1.5 mg) once daily, during 24 days.
      This was followed by a second pill-free interval of 10 days, to allow for sufficient washout
      of NOMAC-E2. On treatment day 35, 20 subjects were to receive 1 tablet NOMAC-E2 (2.5 mg / 1.5
      mg) and 5 subjects were to receive a placebo tablet in a double blinded setup. After
      treatment day 35 and before follow-up, all subjects would again have a pill-free interval of
      7 days. After follow-up, all subjects could return to their own contraceptive schedule.
      Follow-up took place on treatment day 42.

      Bleeding pattern and tablet intake were assessed by means of a subject diary to be completed
      on a daily basis. Blood sampling for pharmacokinetic and pharmacodynamic purposes were
      collected at several time points before, during and after the MD and SD period. In order to
      explore any possible influence of NOMAC-E2 on the QT/QTc interval, a small placebo group was
      designed within the SD period, to allow for comparison with the active-treated group. In
      addition several safety assessments (vital signs, ECGs, trans vaginal ultrasound evaluation,
      physical, gynecological and breast examinations, cervical smear, routine laboratory
      parameters and adverse events) were performed.
    

Intervention name(s): nomegestrol acetate and estradiol
Intervention type(s): Drug
Intervention description(s): Group 1: one tablet of 2.5 mg NOMAC-E2 and 1.5 mg E2 per day on days 1-24 and day 35; Group 2: one tablet of 2.5 mg NOMAC-E2 and 1.5 mg E2 per day on days 1-24 followed by one Placebo tablet on day 35
Other intervention name(s): NOMAC-E2; Org 10486-0 + Org 2317
Intervention MeSH terms: Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: pharmacokinetics (PK); combined oral contraceptive; nomegestrol acetate; estradiol; NOMAC; E2; NOMAC-E2; pharmacokinetics
Individualized Metabolic Assessment and Nutritional Optimization in Children With Chronic Respiratory Insufficiency
Condition: Nutrition
MeSH terms: Respiratory Insufficiency
Study type: Interventional

Summary: 
      The investigators aim to examine the feasibility of individualized diet intervention in
      children dependent on long-term mechanical ventilator support at home. The investigators will
      use a multidisciplinary model that will allow for diet modification based on comprehensive
      nutrition, metabolic and respiratory assessments performed in the subjects' home. the impact
      of this intervention (for 12 weeks) on body composition and respiratory variables will be
      assessed.
    

Detailed description: 
      A strategy of individualized diet intervention and its impact on respiratory and nutritional
      outcomes in children on long-term mechanical ventilation has not been previously evaluated.

      The investigators' objective is to assess the feasibility of individualized diet intervention
      in children dependent on long-term mechanical ventilator support using a multidisciplinary
      model. The investigators will optimize energy intake (based on indirect calorimetric
      measurement) and protein intake (based on recommended intake values) in this group. The
      subjects will be administered the modified diet for 12 weeks, and a comprehensive nutrition,
      metabolic and respiratory assessment will be performed before and after intervention, in the
      subjects' home. The investigators will examine the effect of individualized diet optimization
      on nutritional status, body composition, CO2 production (VCO2) and minute ventilation (MV).

      The investigators hypothesize that optimizing energy and protein intake would be associated
      with improved nutritional status, particularly increment in LBM, and decrease in VCO2 and MV.
      If nutritional optimization is associated with positive outcomes in our study cohort, this
      concept could be generalized to a wider patient population with respiratory insufficiency.
    

Intervention name(s): Changes in energy and protein intake
Intervention type(s): Dietary Supplement
Intervention description(s): Energy intake will be based on accurate measurements of energy expenditure. Protein intake will be matched to age-based recommended values if necessary.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Indirect calorimetry; Protein; Mechanical ventilation; Respiratory failure