bioihbjkbjnl/mcl2 huggingface dataset:
Adrenal Suppression and Absorption Study of Halobetasol Propionate Foam in Subjects 12-17 With Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Halobetasol Topical Foam
Intervention description: Foam
Intervention MeSH terms: Halobetasol
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: 12 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate Halobetasol Propionate (HBP) foam, 0.05% in subjects
      aged 12 through less than 18 years with plaque psoriasis in order to check the safety, the
      potential to suppress the adrenal glands and the degree to which the drug is absorbed into
      the bloodstream.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Subject is male or non-pregnant female and is 12 to less than 18 years of age

          -  Subject has provided written informed assent and was accompanied by the parent or
             legal guardian at the time of assent/consent signing

          -  Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 10%
             Body Surface Area (BSA)

          -  Subject has an Investigator's Global Assessment (IGA) score of at least three (3 =
             moderate) at the Baseline Visit

        Key Exclusion Criteria:

          -  Subject has spontaneously improving or rapidly deteriorating plaque psoriasis

          -  Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis

          -  Subject has a physical condition which, in the investigator's opinion, might impair
             evaluation of plaque psoriasis, adrenal axis function or which exposes the subject to
             an unacceptable risk by study participation

          -  Subject has had prolonged exposure to natural or artificial sources of ultraviolet
             radiation

          -  Subject is pregnant, lactating, or is planning to become pregnant during the study

          -  Subject is currently enrolled in an investigational drug or device study
To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Sildenafil citrate; Sildenafil citrate; Sildenafil citrate; Sildenafil citrate
Intervention description: oral, 20 mg, tid; oral 1 mg, tid; oral 5 mg, tid; oral 20 mg, tid
Intervention MeSH terms: Sildenafil Citrate; Citric Acid; Sodium Citrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To demonstrate a dose response for 1 mg, 5 mg and 20 mg TID oral sildenafil for the treatment
      of subjects with PAH.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with PAH (i.e. IPAH or secondary to connective tissue disease or with
             surgical repair of ASD, VSD, PDA, aorto-pulmonary window) whose baseline six minute
             walk test distance is >/= 100 m and </= 450 m.

          -  Subjects with a mean pulmonary artery pressure of >/= 25 mmHg and a pulmonary artery
             wedge pressure of </= 15 mmHg at rest via right heart catheterization performed within
             12 weeks prior to randomization.

        Exclusion Criteria:

          -  Subjects whose 6 Minute Walk Distance may be limited by conditions other than PAH
             related dyspnoea or fatigue, e.g. claudication from vascular insufficiency or
             significant arthritis.

          -  Subjects who are currently receiving any forms of chronic treatment for PAH such as
             prostacyclin, PDE-5 inhibitors, endothelin-receptor antagonists, nitrates or nitric
             oxide donors (e.g. arginine supplement, nicorandil) in any form, protease inhibitors
             such as ritonavir and saquinavir, ketoconazole, itraconazole, and alpha blockers.
             Subjects previously receiving any of these drugs must have stopped use for a period of
             at least 1 month prior to screening, except in the case of bosentan or prostacyclin (3
             months).
Performance and Safety of Restylane Lidocaine for Treatment of Depressed Facial Acne Scars
Condition: Healthy Volunteers
MeSH terms: Depression
Intervention: Restylane Lidocaine; No-treatment control
Intervention description: Hyaluronic acid based filler; No-treatment control
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 25 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate performance and safety of Restylane Lidocaine for
      treatment of depressed facial acne scars
    

Eligibility criteria:

        Inclusion Criteria:

          -  Intent to undergo treatment of depressed acne scars

          -  Presence of 5-20 scars with a diameter of up to approximately 4 mm within the
             treatment area

          -  Similar type, size and number of scars on both cheeks

          -  Men or non-pregnant, non-breast feeding women

          -  Fitzpatrick skin type I-IV

          -  Signed and dated informed consent to participate in the study

        Exclusion Criteria:

          -  Presence of more than 3 scars per cheek (within the treatment area) of the following
             types: icepick scars or atrophic acne scars with a diameter of > 4 mm.

          -  Active acne with inflammatory component

          -  Use of per oral or topical (facial) substances containing retinoids, bensoyl peroxide,
             alpha-hydroxy acid at concentrations above 10%, beta-hydroxy acid at a concentration
             above 2%, or antibiotic treatment for active acne within 4 months before treatment

          -  Use of isotretinoin within 6 months before treatment

          -  Post-surgical scars in the treatment area

          -  Previous tissue augmenting therapy or contouring with permanent filler or
             fat-injection in the treatment area

          -  Previous tissue augmenting therapy, contouring or revitalisation treatment with
             Calcium Hydroxyapatite (CaHa), or Poly L-Lactic Acid (PLLA), in the treatment area
             within 24 months before treatment

          -  Previous tissue augmenting therapy, contouring or revitalisation treatment with
             non-permanent filler such as hyaluronic acid (HA) or collagen in the treatment area
             within 12 months before treatment

          -  Previous tissue revitalisation treatment with neurotoxin, laser or light, mesotherapy,
             chemical peeling or dermabrasion in the treatment area within 6 months before
             treatment

          -  Previous surgery including aesthetic facial surgical therapy, liposuction, or tattoo
             in the treatment area

          -  Any medical condition that, in the opinion of the treating Investigator, would make
             the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease
             that may interfere with the outcome of the study)
Triferic AVNU Infusion Via Freedom Pump During Hemodialysis
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Intervention: Triferic AVNU
Intervention description: Ferric Pyrophosphate Citrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate the delivery of Triferic AVNU intravenously
      using the Freedom Pump-20 during hemodialysis into the pre-dialyzer and post-dialyzer blood
      lines.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participant must be 18 years of age inclusive, at the time of signing the informed
             consent.

          2. Receiving chronic hemodialysis for 3-4 hours each session 3x/week.

          3. Medically stable according to the investigator opinion

          4. Capable of giving signed informed consent which includes compliance with the
             requirements and restrictions listed in the informed consent form (ICF) and in this
             protocol.

        Exclusion Criteria:

          1. Hemodynamically unstable during hemodialysis

          2. Evidence of active bleeding from the GI tract.
Xyrem and Brain Dopamine in Narcolepsy
Condition: Narcolepsy With Cataplexy; Healthy Controls
MeSH terms: Narcolepsy; Cataplexy
Intervention: Xyrem
Intervention description: single 3.0 gram dose
Intervention MeSH terms: Sodium Oxybate
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be recruited to fill 2 separate study groups: 1) participants with a diagnosis of narcolepsy with cataplexy; 2) healthy controls.
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Xyrem; narcolepsy with cataplexy; positron emission tomography; dopamine

Summary:

      The overall aim of this investigation is to establish whether an action of Xyrem® on the
      brain dopamine system in patients with narcolepsy, and in a comparison control group, might
      explain part of the anti-narcoleptic effect of the drug.

      Trial Objective is to establish, using positron emission tomography (PET), in Xyrem®-naïve
      narcolepsy with cataplexy patients, and in matched controls, whether a single dose of Xyrem®
      causes changes in striatal binding of 11C-raclopride and 11C-DTBZ that would suggest altered
      activity of brain dopamine neurones.
    

Eligibility criteria:

        Inclusion Criteria:

          -  current diagnosis of narcolepsy with cataplexy OR healthy control

        Exclusion Criteria:

          -  use of any sedative hypnotics, tranquilizers, anticonvulsants, antihistamines (except
             non-sedating), benzodiazepines, clonidine or any medication known to affect dopamine
             at start of baseline period

          -  significant unstable or uncontrolled medical/psychiatric disease

          -  significant history of head trauma/surgery or seizure disorder

          -  radiation exposure exceeding 20mSv in last 12 months

          -  pregnancy

          -  substance abuse/dependence (including alcohol)

          -  have sleep apnea, or are shift workers

          -  on a sodium-restricted diet

          -  has ever taken Xyrem / sodium oxybate / GHB at any time

          -  claustrophobia

          -  metal implants / objects in the body that may interfere with MRI

          -  succinic semialdehyde dehydrogenase deficiency
Lundbeck TOMs Orthostatic Hypotension
Condition: Orthostatic Hypotension; Idiopathic Parkinson Disease
MeSH terms: Parkinson Disease; Hypotension, Orthostatic; Hypotension
Intervention: Droxidopa 100 MG [Northera]
Intervention description: droxidopa taken three times a day titrated up to a maximum of 600 mg.
Intervention MeSH terms: Droxidopa
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Orthostatic hypotension (OH), which consists in a significant reduction in blood pressure
      levels upon standing from a seated position, may affect approximately one in three patients
      with Parkinson's disease (PD). It usually presents as dizziness, lightheadedness, feeling
      faint, or feeling like you might black out while standing. This can significantly impact the
      quality of life (QoL) of PD patients, resulting in difficulties with balance, walking, and
      increased risk of falls. The main aim of this study is to evaluate whether the use of
      technological devices (a computerized system for analyzing abnormalities in walking in
      clinical settings and a wearable sensor to detect changes in postural unsteadiness in the
      home environment) may improve the detection of complications and the response to medical
      therapies for OH in patients with PD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of idiopathic Parkinson's Disease, meeting UK Brain Bank criteria for at
             least 3 years

          -  Hoehn and Yahr (H&Y) stage I-III

          -  Age between 30 and 80 years old (both inclusive)

          -  Stable dosage of dopaminergic medications for at least 4 weeks

          -  Orthostatic Hypotension, defined as a fall in systolic BP ≥ 20 mmHg or diastolic BP ≥
             10 mmHg within 3 minutes of standing

          -  Willingness and ability to comply with scheduled visits

        Exclusion Criteria:

          -  Diabetes mellitus or other diseases potentially associated with autonomic dysfunction

          -  Treatment with antihypertensive drugs or with alpha-adrenergic antagonists

          -  Cognitive impairment, defined as a score < 24 at the Montreal Cognitive Assessment
             (MoCA)

          -  Any atypical signs lowering the diagnostic certainty for PD

          -  Lack of postural reflex defined as a score > 2 at the MDS-UPDRS item 3.12 (recover at
             the pull test)

          -  Severe levodopa induced dyskinesia, defined as an MDS-UPDRS item 4.2 > 2 (functional
             impact of dyskinesia)
Genetically Informed Smoking Cessation Trial
Condition: Smoking Cessation
Intervention: Combination NRT (Nicotine patch, Nicotine lozenge); Varenicline; Placebo; Intensive smoking counseling
Intervention MeSH terms: Nicotine; Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 822.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Smoking cessation; Counseling; Genetics and Genomics

Summary:

      The investigators' goal is to identify the most appropriate smoking cessation treatments for
      smokers based on genetic information. Smokers try to quit smoking but relapses are common.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult (≥21 years of age), seeking treatment for smoking cessation.

          2. Able to speak English,

          3. Active smoking (Cigarettes Per Day (CPD) ≥5), and exhaled Carbon Monoxide (CO) ≥8 ppm

          4. Agree to participate in this randomized smoking cessation trial with follow up
             assessments up to 12 months.

        Exclusion Criteria:

          1. Pregnancy or breast feeding,

          2. Active use or recent use (< or equal to 1 month) of medication or e-cigarettes for
             nicotine dependence/smoking cessation, or use of e-cigarettes for more than 9 days in
             the prior month,

          3. Allergy to nicotine patch, lozenge, or varenicline,

          4. Unwillingness to prevent pregnancy during the medication phase and 1 month afterwards
             (women only),

          5. Significant cardiac conditions (myocardial infarction, unstable angina, coronary
             angioplasty, cardiac bypass) or serious arrhythmia in past 6 months,

          6. Current heavy alcohol consumption (≥6 drinks/day, 6 days/week),

          7. Active psychosis or poorly controlled depression within the past 6 months,

          8. Any prior suicide attempt or suicidal ideation within the past 6 months,

          9. End stage renal disease with hemodialysis.
Does Rosuvastatin Delay Progression of Atherosclerosis in HIV
Condition: HIV; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Atherosclerosis
Intervention: Rosuvastatin; Placebo
Intervention description: encapsulated tablet 20mg daily; Placebo arm included to maintain blinding
Intervention MeSH terms: Rosuvastatin Calcium
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: HIV; Cardiovascular disease; Inflammation; Statin

Summary:

      This study is a randomised double blind placebo controlled trial comparing Rosuvastatin with
      placebo in HIV positive people who are at intermediate cardiovascular risk.

      It is possible that HIV positive people will receive a greater benefit from statins because
      of their higher baseline levels of inflammation. Current Australian guidelines recommend
      initiation of statin therapy on the basis of cholesterol level and the presence of other risk
      factors for heart disease (such as diabetes) but do not take into account whether a patient
      is infected with HIV. This study aims to determine what benefit HIV infected people will
      receive from starting statin therapy earlier then currently recommended.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  Moderate cardiovascular disease (CVD) risk, (10-15% 10 year risk of CVD)

          -  HIV positive

          -  Stable combination anti-retroviral therapy (cART) with plasma HIV viral load
             <200copies/ml for ≥ 6 months

        Exclusion Criteria:

          -  Recommended use of lipid lowering therapy according to Australian guidelines

          -  Prior use of statin, fibrate, ezetimibe within the last six months

          -  Contraindication to statin use
Mycophenolate Mofetil and Tacrolimus Versus Tacrolimus for the Treatment of Idiopathic Membranous Glomerulonephritis
Condition: Glomerulonephritis, Membranous
MeSH terms: Glomerulonephritis; Glomerulonephritis, Membranous
Intervention: tacrolimus; tacrolimus and mycophenolate mofetil
Intervention description: tacrolimus 2mgs bd adjusted to obtain levels of 5-12ng/ml; tacrolimus 2mg bd adjusted to achieve levels of 5-12ng/L mycophenolate mofetil 500mgs bd adjusted to achieve levels of 1.5-3mg/L
Intervention MeSH terms: Mycophenolic Acid; Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Glomerulonephritis

Summary:

      Study Hypothesis: When mycophenolate mofetil is added to tacrolimus in the treatment of
      membranous glomerulonephritis it is likely to improve the initial response to treatment and
      reduce the risk of relapse on stopping therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Idiopathic membranous glomerulonephritis on renal biopsy

          -  Proteinuria - protein/creatinine ratio (PCR) > 100 units with hypoalbuminaemia or PCR
             > 300 units with normal serum albumin despite 3 months treatment with maximum
             tolerated doses of ace inhibitors and angiotensin 2 antagonists (or shorter if life
             threatening complications of nephrotic syndrome require institution of immediate
             immunosuppression)

          -  Male or female patients aged 18 to 80 years

        Exclusion Criteria:

          -  Hepatitis B hepatitis C or HIV positive

          -  Malignancy (all patients must have a CT chest abdomen and pelvis and other
             investigations if clinically indicated)

          -  Untreated infection

          -  Females who are pregnant, breast feeding, or at risk of pregnancy and not using a
             medically acceptable form of contraception

          -  Any condition judged by the investigator that would cause the study to be detrimental
             to the patient
Isopropyl Alcohol vs Ondansetron for Nausea in the Emergency Department
Condition: Nausea
MeSH terms: Emergencies; Nausea
Intervention: Inhaled isopropyl alcohol; Oral ondansetron; Inhaled normal saline; Oral placebo
Intervention description: Patients will inhale from isopropyl alcohol pads as needed for nausea up to q30 minutes.; Patients will drink elixir containing 4 mg ondansetron in 5 ml of solution. National Drug Code (NDC) 0054-0064-47.; Patients will inhale from normal saline pads as needed for nausea up to q30 minutes.; Subjects will drink solution comprised of 0.25 ml of Oral Sweet Sugar Free NDC 0574-0302-16 with 4.75 ml of sterile water for dilution NDC 0264-2101-00
Intervention MeSH terms: Ondansetron
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will compare the efficacy of isopropyl alcohol and conventional anti-emetics with
      three study arms: (1) inhaled isopropyl alcohol plus oral ondansetron; (2) inhaled isopropyl
      alcohol plus oral placebo; (3) inhaled placebo plus oral ondansetron.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ages 18 and older

          -  complaint of nausea and/or vomiting reported at 3 or above on verbal numerical rating
             scale at the time of triage

        Exclusion Criteria:

          -  allergy to isopropyl alcohol or ondansetron

          -  inability to breathe through nose (e.g., recent upper respiratory infection)

          -  intake of cefoperazone, disulfiram, or metronidazole within the last 24 hours

          -  mental status precluding informed consent including intoxication

          -  known QT-prolongation

          -  clinical suspicion for serotonin syndrome

          -  intravenous catheter in place prior to study start

          -  medications administered since patient arrival (e.g., in triage)