bioihbjkbjnl/mcl2 huggingface dataset:
Management of Mineral and Bone Disease in Hemodialysis-Calcitriol vs. Paricalcitol
Condition: Kidney Failure; Secondary Hyperparathyroidism; Hyperphosphatemia; Hypercalcemia
MeSH terms: Bone Diseases; Renal Insufficiency; Hyperphosphatemia; Hypercalcemia; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: Calcitriol; Paricalcitol
Intervention description: 3 times weekly; 3 times weekly
Intervention MeSH terms: Calcitriol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this non-inferiority study is to compare the safety and effectiveness of a
      mineral and bone disease treatment protocol based on calcitriol to one based on paricalcitol
      in hemodialysis patients using revised Kidney Disease: Improving Global Outcomes (KDIGO)
      parathyroid hormone targets.
    

Eligibility criteria:

        Inclusion Criteria:

        - All subjects will have been treated for at least three months on hemodialysis with IV
        paricalcitol. These subjects must have a most recent calcium level within the normal range,
        most recent phosphorus level < 8 mg/dL and a most recent PTH between 130-585 pg/mL

        Exclusion Criteria:

        Patients will be excluded if:

          1. age greater than 18

          2. active malignancy

          3. expected survival greater than 6 months

          4. high likelihood of renal transplant during the study period.

          5. Low calcium bath

          6. prior parathyroidectomy

          7. use of calcimimetics
Lipids of the Human Tear Film and Their Effect on Tear Stability
Condition: Blepharitis
MeSH terms: Blepharitis
Intervention: doxycycline; azithromycin
Intervention description: Oral doxycycline 100mg bid; topical 1% azithromycin daily to eye
Intervention MeSH terms: Azithromycin; Doxycycline; Minocycline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meibomian gland dysfunction; Lid margin disease; doxycycline; azithromycin; essential fatty acid

Summary:

      This prospective, randomized, comparative clinical trial evaluates the effect of either oral
      doxycycline, oral essential fatty acid, or topical azithromycin to modify the secretions of
      the meibomian gland in subjects with meibomian gland dysfunction and/or dry eye disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meibomian gland dysfunction

        Exclusion Criteria:

          -  Lid margin scarring; herpetic blepharitis
A Study to Evaluate the Safety and Immunogenicity of Monovalent OPV2 in Children Aged 1 to 5 Years in Lithuania
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Intervention: Sabin mOPV2
Intervention description: Polio Sabin™ Mono Two (oral) is a licensed, monovalent, live attenuated poliomyelitis virus vaccine of the Sabin strain Type 2 (P 712, Ch, 2ab), propagated in MRC5 human diploid cells. Each two-drop dose (0.1 mL) contains not less than 105.0 CCID50 of Type 2. Magnesium chloride is used as a stabilizer. Polio Sabin™ Mono Two (Oral) contains trace amounts of neomycin sulphate and polymyxin B sulphate.
One dose of vaccine (0.1 mL) is contained in two drops which are delivered from the polyethylene dropper supplied with vaccine.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 1 Year
Maximum age: 5 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A Phase 4 study to evaluate the safety and immunogenicity of monovalent oral polio vaccine
      type 2 in healthy IPV-vaccinated children aged 1 to 5 years in Lithuania.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 1 to 5 years of age, previously vaccinated with three or four doses of IPV.

          2. Healthy without obvious medical conditions that preclude entry of the subject into the
             study as established by the medical history and physical examination.

          3. Written informed consent obtained from 1 or 2 parent(s) or legal guardian(s) as per
             country regulations.

        Exclusion Criteria:

          1. Previous vaccination against poliovirus outside the national immunization schedule.

          2. Any confirmed or suspected immunosuppressive or known immunodeficient condition
             including human immunodeficiency virus (HIV) infection.

          3. Family history of congenital or hereditary immunodeficiency.

          4. Major congenital defects or serious uncontrolled chronic illness (neurologic,
             pulmonary, gastrointestinal, hepatic, renal, or endocrine).

          5. Known allergy to any component of the study vaccines or to any antibiotics.

          6. Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the study period.

          7. Acute severe febrile illness at day of vaccination deemed by the Investigator to be a
             contraindication for vaccination (the child can be included at a later time if within
             age window and all in/exclusion criteria are met.).

          8. Member of the subject's household (living in the same house or apartment unit) has
             received OPV in the last 3 months.

          9. Subject who, in the opinion of the Investigator, is unlikely to comply with the
             protocol or is inappropriate to be included in the study for the safety or the
             benefit-risk ratio of the subject.
Two Stepped Care Models for Posttraumatic Stress Disorder (PTSD) Among Cambodian Refugees With PTSD
Condition: Posttraumatic Stress Disorder (PTSD)
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Medication augmentation; CBT
Intervention MeSH terms: Prazosin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 114.0
Sex: All
Minimum age: 43 Years
Healthy volunteers: No
Keywords: PTSD; Cognitive behavioral therapy (CBT); Medication augmentation; Treatment-resistant PTSD; Cambodian refugees; Culturally sensitive treatment

Summary:

      This project aims to investigate the efficacy of two models to treat Posttraumatic Stress
      Disorder (PTSD) for Cambodian refugees in primary care. The first step in both models is
      giving a medication, which is a serotonin reuptake inhibitor/serotonin-norepinephrine
      reuptake inhibitor (SSRI/SSRN), with paroxetine being the first-line agent. For those
      patients who still have PTSD, the second step is either another medication or a culturally
      sensitive cognitive behavioral therapy (CBT). The investigators hypothesize that patients
      will improve in both models, but more so in the the CBT model.
    

Eligibility criteria:

        Inclusion Criteria:

          -  PTSD;

          -  PCL great or equal to 44;

          -  Survivor of the Cambodian genocide;

          -  At least 7 years old at the time of the Cambodian genocide

        Exclusion Criteria:

          -  Pregnant;

          -  Active suicidality;

          -  Mental retardation;

          -  Organic mental disorder;

          -  Bipolar disorder;

          -  Alcohol dependence;

          -  Marijuana dependence;

          -  Unable to give conformed consent
A Study of the Efficacy of Botox in the Treatment of Social Anxiety Disorder
Condition: Anxiety Disorder Social; Anxiety
MeSH terms: Anxiety Disorders; Phobia, Social
Intervention: botulinum toxin A; Placebo
Intervention description: Single treatment visit for 5 injections of botulinum toxin A, 40 units (for females) and 50 units (for males)/; single treatment visit for 5 injections of normal saline
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: social anxiety; botulinum toxin; botox

Summary:

      The goal of this study is to see whether Botox is an effective treatment for social anxiety
      disorder (SAD). Participants will complete two short surveys on depression and anxiety
      symptoms, receive a one-time injection of Botox, and complete the depression and anxiety
      survey 4 weeks after injection and again at 8 weeks after injection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  primary diagnosis of social anxiety disorder

          -  women of childbearing potential on an acceptable form of birth control and are not
             pregnant or lactating

        Exclusion Criteria:

          -  has ever been treated with botulinum toxin A

          -  has another Axis I diagnosis within in the 6-months prior to screening

          -  history of substance abuse within 2-months of screening

          -  current or recent suicidality

          -  scoring greater than 2 on Beck Depression Inventory (BDI) suicidality question

          -  psychotic or bipolar disorder

          -  unstable medical condition

          -  changes in medication or psychotherapy treatment in the month prior to screening

          -  significant risk of committing homicide
Treatment of Adolescent Antimuscarinic (Anticholinergic) Toxidrome
Condition: Anticholinergics Toxicity
Intervention: Physostigmine; Lorazepam
Intervention description: Administration of physostigmine bolus followed by an infusion; Administration of lorazepam bolus followed by normal saline infusion
Intervention MeSH terms: Lorazepam; Physostigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 19.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Overdose of xenobiotics (antihistamines, antipsychotics, or Jimson Weed) with resulting
      antimuscarinic toxidrome is a common scenario in medical toxicology. The result of antagonism
      of muscarinic receptors is a constellation of signs and symptoms (toxidrome): mydriasis,
      decreased sweat, decreased bowel sounds, agitation, delirium, hallucinations, urinary
      retention, tachycardia, flushed skin and seizures. Two treatment options are physostigmine or
      benzodiazepines.

      Although the antimuscarinic toxidrome occurs commonly, physostigmine has been used sparingly
      despite evidence of safety and efficacy. To demonstrate the utility and safety of
      physostigmine, the investigators propose a randomized clinical trial of physostigmine
      compared to benzodiazepine for antimuscarinic toxicity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >=10 and < 18 years

          -  Present to the Emergency Department or Intensive Care Unit for an antimuscarinic
             toxidrome from either a pharmaceutical agent such as antihistamine overdose, or
             natural toxins or products such as Datura stramonium

          -  Antimuscarinic toxidrome will be defined with at least one central nervous system
             agitation effect (agitation, delirium, visual hallucinations, mumbling
             incomprehensible speech), and at least 2 peripheral nervous system adverse effect
             (mydriasis, dry mucus membranes, dry axillae, tachycardia, decreased bowel sounds).

          -  Patients will also be required to have a RASS score of +2 to +4 on initial assessment.

        Exclusion Criteria:

          -  History of seizures or seizure during acute clinical course

          -  History of asthma or wheezing during clinical course Bradycardia (Heart Rate <60)

          -  Concomitant use of atropine or choline ester or depolarizing neuromuscular blocker
             during present illness and hospital course

          -  Diabetes gangrene, known intestinal obstruction or urogenital tract, vagotonic state

          -  QRS interval > 120 ms on electrocardiogram

          -  Known to be pregnant at the time of enrollment

          -  Known ward of the state
Paricalcitol Versus Calcitriol for the Management of Renocardiac Syndrome in Renal Transplant Patients
Condition: Cardiorenal Syndrome; Chronic Allograft Nephropathy
MeSH terms: Kidney Diseases; Cardio-Renal Syndrome; Syndrome
Intervention: Paricalcitol; Calcitriol; Cholecalciferol; Supplemental
Intervention description: paricalcitol group (6-8 μg daily per os - orally - without special diet); calcitriol group (2-4 μg daily orally under with dietary restrictions of vitamin D); cholecalciferol group (intake of cholecalciferol with recommended daily allowance equals 1200-2400 IU per day); intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
Intervention MeSH terms: Cholecalciferol; Vitamin D; Calcitriol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 109.0
Sex: Male
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: chronic allograft nephropathy; stem-progenitor cells; cardiorenal syndrome; calcitriol; paricalcitol; cholecalciferol; cardiac repair; renal repair

Summary:

      We hypothesize that paricalcitol and calcitriol in dose-dependent manner are effective for
      the management of chronic allograft dysfunction (CAD), protection and repair of kidney and
      heart, management of chronic renocardiac syndrome (CRS). We assume that paricalcitol can have
      some advantages if compare with calcitriol or cholecalciferol due to absence of calcemic and
      phosphatemic complications alongside with great beneficial potential.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 40-75

          -  Male

          -  History of chronic kidney disease and cardiorenal syndrome

          -  Written informed consent

        Exclusion Criteria:

          -  Female

          -  Acute illness

          -  Life-threat competitive illness

          -  Mental disorders

          -  Endocrinologic diseases (including diabetes mellitus, hyperparathyroidism, and other
             thyroid disorders)

          -  Need for dialyses

          -  Hypercalcemia

          -  Concomitant use of hormone or cytokine medication

          -  Participation to any drug-investigation during the previous 60 days as checked with
             VIP check
Effect of Aliskiren and Hydrochlorothiazide on Kidney Oxygenation in Patients With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Aliskiren; Hydrochlorothiazide
Intervention description: Drug therapy will be started with an initial 2 weeks on Aliskiren 150 mg followed by a titration to 300 mg Aliskiren if the treatment is well tolerated. A first baseline measurements will be performed before initiating therapy and a second after 8 weeks of treatment (24h after last drug intake) to assess the chronic effect.; Drug therapy will be started with an initial 2 weeks HCTZ 12.5 mg followed by a titration to 25 mg HCTZ if the treatment is well tolerated. A first baseline measurements will be performed before initiating therapy and a second after 8 weeks of treatment (24h after last drug intake) to assess the chronic effect.
Intervention MeSH terms: Hydrochlorothiazide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Kidney oxygenation; Stage 1 or 2 hypertension; BOLD-IRM

Summary:

      The goal of this project is to evaluate the chronic effect (8 weeks) of RASILEZ 300mg
      (aliskiren) on renal tissue oxygenation in patients with stage 1-2 hypertension, and to
      compare the chronic effect (8 weeks) of RASILEZ 300mg (aliskiren) on renal tissue oxygenation
      in patients with stage 1-2 hypertension with these effects with those of ESIDREX 25mg
      (hydrochlorothiazide).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Tolerance to study drugs

          -  Age > 18 years

          -  Arteria hypertension stage 1-2 (blood pressure: 140/90 and 180/110 mm Hg)

          -  Normal renal function

          -  Availability to give informed consent

        Exclusion Criteria:

          -  Intolerance to study drugs

          -  Renal artery stenosis

          -  Hyperkalaemia > 5.0 mmol/l

          -  Contra-indications to the use of PAH, inulin or Lithium

          -  Asthma

          -  Pychiatric illness

          -  No estimated easy vascular venous access for placement of two peripherical venous
             catheters in forearms

          -  Contra-indication to MRI-imaging: Claustrophobia or Pacemaker or other implanted metal
             device
Glucocorticoid Receptor Blockade With Mifepristone in Patients With Mild Adrenal Hypercortisolism
Condition: Mild Hypercortisolism
MeSH terms: Cushing Syndrome; Adrenocortical Hyperfunction
Intervention: Mifepristone
Intervention description: All patients in the study will receive daily Mifepristone for 6 months and primary and secondary outcomes will be assessed before and after the 6 month treatment period
Intervention MeSH terms: Mifepristone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: mild hypercortisolism; Subclinical Cushing's Syndrome; Preclinical Cushing's Syndrome

Summary:

      The purpose of this study is to determine whether mifepristone is an effective treatment for
      hyperglycemia due to mild hypercortisolism.

        -  To test the hypothesis that GR blockade with mifepristone will decrease the severity of
           metabolic syndrome features as measured by waist circumference, lipid profile, body mass
           index, blood pressure and insulin resistance, measured by HOMA-IR score.

        -  To test the hypothesis that GR blockade with mifepristone will improve QoL, depression
           and anxiety scores, measured by validated assessments, in patients with mild
           hypercortisolism.
    

Eligibility criteria:

        Inclusion Criteria:

          -  >18 years of age

          -  Incidentally noted adrenal nodule <4 cm with benign imaging characteristics

          -  Evidence of mild hypercortisolism

          -  Evidence of diabetes or abnormal glucose tolerance

        Exclusion Criteria:

          -  contraindication to mifepristone

          -  Indication for unilateral adrenalectomy

          -  Evidence of other adrenal hormone hypersecretion

          -  lactating mothers

          -  women of childbearing age unwilling to use an effective, nonhormonal form of
             contraception
DisCoVisc Versus DuoVisc, Healon5 and AmVisc Plus
Condition: Cataract
MeSH terms: Cataract
Intervention: DisCoVisc; DuoVisc; Healon5; Amvisc Plus
Intervention description: Use of DisCoVisc Ophthalmic Viscosurgical Device (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) during cataract surgery.; Use of DuoVisc viscoelastic system consisting of Viscoat (3% sodium hyaluronate, 4% chondroitin sulfate)and Provisc(1% sodium hyaluronate) during cataract surgery.; Use of Healon5 ophthalmic viscosurgical device (2.3% Sodium Hyaluronate) during cataract surgery.; Use of Amvisc Plus ophthalmic viscosurgical device (1.6% Sodium Hyaluronate) during cataract surgery.
Intervention MeSH terms: Hyaluronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 112.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Discovisc; Ophthalmic Viscosurgical Device

Summary:

      A comparison of the ability of DisCoVisc to that of other ophthalmic viscosurgical devices
      (OVDs) (DuoVisc, Healon5 or Amvisc PLUS) regarding endothelial protection and anterior
      chamber space maintenance during non-eventful cataract surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  operable cataracts in at least one eye

        Exclusion Criteria:

          -  Endothelial Cell Count (ECC) ≤1500cells/mm2

          -  Intraocular Pressure (IOP) > 21mm Hg

          -  previous ocular inflammation

          -  systemic or ocular conditions affecting corneal endothelium
Patient Centered Outcomes in Rosacea: An Exploratory Multi-media Analysis of the Patient Experience on Oracea
Condition: Papulopustular Rosacea
MeSH terms: Rosacea
Intervention: Oracea
Intervention MeSH terms: Doxycycline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 25 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Papulopustular Rosacea; Oracea; anti inflammatory doxycycline

Summary:

      The purpose of this study is to characterize rosacea patients', being treated with Oracea,
      perception through visual analog scale reporting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women

          -  25-70 years

          -  Diagnosis of papulopustular rosacea

          -  Eligible for Oracea treatment

        Exclusion Criteria:

          -  Allergies to components of investigational product and/or hypersensitivity to
             tetracyclines

          -  Taken systemic therapy directed at improving rosacea, including antibiotics, within 30
             days prior to baseline visit

          -  Used topical rosacea treatment within 30 days prior to baseline visit

          -  Have active ocular rosacea and/or blepharitis/meibomianitis requiring systemic
             treatment by an opthalmologist

          -  Previously failed to have improvement of rosacea with appropriate use of systemic
             tetracycline family of antibiotics

          -  Exposed to intense/excessive ultraviolet (UV) radiation within one week prior to
             baseline and/or who forsee unprotected and intense/excessive UV exposure during the
             course of the study

          -  Have planned surgical procedures during the course of the study

          -  Have used tetracycline antibiotics within 30 days prior to baseline visit or during
             study

          -  At risk in terms of precautions, warnings, and contraindications