bioihbjkbjnl/mcl2 huggingface dataset:
Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) of Cervical Intraepithelial Neoplasia (CIN) Grade 1
Condition: Cervical Intraepithelial Neoplasia
MeSH terms: Neoplasms; Carcinoma in Situ; Uterine Cervical Dysplasia
Intervention: Hexaminolevulinate (HAL); Placebo; Hexaminolevulinate (HAL); Placebo
Intervention description: Drug: hexaminolevulinate (HAL) Suppository HAL 100 mg for 3-7 hours application; Placebo suppository, for 3-7 hours application; Drug: hexaminolevulinate (HAL) Ointment HAL 100 mg for 5 hours application; Placebo ointment for 5 hours application
Intervention MeSH terms: Aminolevulinic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 83.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cervical intraepithelial neoplasia (CIN)

Summary:

      The study will examine the effect of HAL vs placebo photodynamic therapy of low-grade
      cervical precancerous lesions (dysplasia) in women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Satisfactory colposcopy examination

          -  Negative endocervical canal by colposcopy

          -  Ectocervical CIN1 as verified by local pathologist (biopsy).

          -  Colposcopical visible lesion at visit 2, before photoactivation

          -  Written Informed Consent signed

          -  Age 18 or above

        Exclusion Criteria:

          -  Previous treatment of CIN or invasive disease or suspicion of either micro-invasive or
             invasive disease

          -  Malignant cells on cytology or histology

          -  Atypical glandular cells (AGC) or adenocarcinoma in situ (AIS) on cytology

          -  Suspicion of endocervical disease on colposcopy

          -  Current pelvic inflammatory disease, cervicitis, or other gynecological infection as
             per colposcopy and clinical examination

          -  Known or suspected porphyria

          -  Known allergy to hexaminolevulinate or similar compounds (e.g. methyl aminolevulinate
             or aminolevulinic acid)

          -  Use of heart pacemaker

          -  Pregnancy

          -  Nursing

          -  Childbirth or miscarriage within six weeks of enrolment - Known

          -  Participation in other "competitive" clinical studies either concurrently or within
             the last 30 days

          -  Risk of poor protocol compliance

          -  Not willing to use adequate birth control from screening until last PDT

          -  Subject is the investigator or any sub-investigator, research assistant, pharmacist,
             study coordinator, other staff or relative thereof directly involved in the conduct of
             the protocol.
A Study in Adults and Adolescents With Angelman Syndrome (STARS)
Condition: Angelman Syndrome
MeSH terms: Angelman Syndrome; Syndrome
Intervention: OV101 Regimen 1; OV101 regimen 2; Placebo
Intervention MeSH terms: Gaboxadol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 88.0
Sex: All
Minimum age: 13 Years
Maximum age: 49 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to assess the safety and tolerability of oral OV101 (gaboxadol)
      in adult and adolescent subjects with Angelman syndrome. In addition, several exploratory
      efficacy outcome measures will be investigated.
    

Eligibility criteria:

        Inclusion Criteria

          1. Age 13- 49 years

          2. Diagnosis of Angelman syndrome

          3. Receiving a stable regimen of concomitant medications for at least 4 weeks prior to
             Baseline, and able to maintain these throughout the duration of the study

          4. Has a caregiver capable of providing informed consent on behalf of the subject and
             able to attend scheduled study visits

          5. Able to ingest study medication

          6. Caregivers must agree not to post any subject or study information on social media

        Exclusion Criteria

          1. Unable to perform the study related safety and exploratory efficacy assessments, such
             as motor function

          2. Poorly controlled seizure activity

          3. Concomitant cardiovascular, respiratory, liver, renal, or hematologic diseases of a
             degree that would limit participation in the study

          4. Pregnancy or women of child-bearing potential who are not using and acceptable method
             of contraception

          5. Concomitant use of minocycline, levodopa, zolpidem, zaleplon, eszopiclone, ramelteon,
             and cannabinoid derivatives, or any other use of any investigational agent, device,
             and/or investigational procedure 4 weeks prior to Baseline and during the study

          6. Allergy to OV101 or any excipients

          7. At increased risk of harming self and/or others based on investigator assessment

          8. Any condition or reason that in the opinion of the investigator makes the subject
             unsuitable for enrollment

          9. Inability of subject or caregiver to comply with study requirements

        Other protocol-defined inclusion/exclusion criteria may apply.
Safety and Efficacy Study of Citalopram and Lithium for the Treatment of Depressive Mood Disorder Symptoms
Condition: Major Depressive Disorder; Dysthymia; Depression Not Otherwise Specified; Borderline Personality Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Personality Disorders; Mood Disorders; Borderline Personality Disorder; Dysthymic Disorder
Intervention: Lithium Carbonate; Placebo; Citalopram
Intervention description: 300 mg one time per day for 4 weeks; Take one time daily for 4 weeks; All patients will be administered Citalopram 20 mg to to be taken once daily, by mouth for the duration of the double-blind treatment phase (4 weeks)
Intervention MeSH terms: Lithium Carbonate; Citalopram
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: hopelessness; alone; sad; troubled; depression

Summary:

      The investigators hypothesize that patients receiving citalopram in combination with lithium
      will have a greater reduction in depressive symptoms than patients receiving citalopram in
      combination with placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-75 years of age

          -  Meets criteria for Major Depressive Disorder, Dysthymia, Depression Not Otherwise
             Specified or Borderline Personality Disorder

          -  Ability to speak, read and understand the English Language and provide written
             informed consent

        Exclusion Criteria:

          -  Current, unstable and significant medical condition or illness

          -  History of Thyroid disorder, seizure disorder, tumors or other CNS condition that
             predisposes the patient to risk of seizure

          -  Pregnant or lactating females

          -  Abnormal clinical laboratory test results

          -  Intolerance or hypersensitivity to SSRIs or lithium

          -  History or current diagnosis of bipolar mood disorder, psychosis, schizophrenia or
             dementia

          -  Certain mediations my not be used prior or during the study
Efficacy and Safety of Dexamethasone Nanoparticles Eye Drops in Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: Dexamethasone nanoparticles eye drops
Intervention description: DexNP 15 mg/mL eye drops 3 times a day (every 8 hours) for 12 weeks
Intervention MeSH terms: Dexamethasone; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 144.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      Anti-inflammatory or anti-angiogenic drugs play an ever- increasing role in the treatment of
      diabetic macular edema (DME). The drug delivery systems, such as injections of corticosteroid
      and or vascular endothelial growth factor (VEGF) antibodies into the vitreous cavity or slow
      release drug capsules surgically implanted in the eyes run the risk of surgical complications
      including infections, hemorrhages and cataracts and place a huge demand on eye care resources
      significantly increase the risk of cardiovascular events and death.

      A non-invasive drug delivery platform with steroid eye drops, reaching the back of the eye to
      treat DME and other retinal diseases would circumvent most of these problems.

      A novel drug delivery platform is required for ocular therapy. Oculis ehf. has developed a
      drug delivery platform, which is based on cyclodextrin nanoparticles that dissolve in the
      tear fluid to form water-soluble drug/cyclodextrin complex nanoparticles. Animal and initial
      clinical testing has shown the potential for this technology to increase the drug
      concentration in the eye tissues including the retina and therefore treat retinal diseases
      like DME.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Had DME of less than 3 years duration since diagnosis with presence of intraretinal
             and/or subretinal fluid in the study eye, with CMT of ≥ 310 µm by SD-OCT at baseline
             (Visit 2) (as measured by the Investigator).

          2. Had definite retinal thickening in the study eye due to DME involving the central
             macula based on the Investigator's clinical evaluation and by SD-OCT;

             ...

        Key Exclusion Criteria:

          1. Had macular edema considered to be due to a cause other than DME;

          2. Had a decrease in BCVA due to causes other than DME (e.g., foveal atrophy, pigment
             abnormalities, dense subfoveal hard exudates, previous vitreoretinal surgery, central
             serous retinopathy, non-retinal condition, substantial cataract, macular ischemia)
             that is likely to be decreasing BCVA by 3 lines or more (i.e., cataract would be
             reducing acuity to 20/40 or worse if eye was otherwise normal).

             ...
Pharmacokinetic-pharmacodynamic Analysis of Sugammadex in Children
Condition: Anesthesia, General; Neuromuscular Blockade
Intervention: Sugammadex Injection 2mg/kg; Sugammadex Injection 4mg/kg; Sugammadex Injection 8mg/kg; Neuromuscular reversal agent injection
Intervention description: Intravenous injection of 2mg/kg of sugammadex sodium 15 minutes after rocuronium administration; Intravenous injection of 4mg/kg of sugammadex sodium 15 minutes after rocuronium administration; Intravenous injection of 8mg/kg of sugammadex sodium 15 minutes after rocuronium administration; Intravenous injection of 0.02mg/kg of atropine and 0.03mg/kg of neostigmine
Intervention MeSH terms: Atropine; Neostigmine
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: sugammadex; pharmacokinetics; pharmacodynamics; pediatric anesthesia

Summary:

      This study administers sugammadex sodium to pediatric patients under general anesthesia with
      rocuronium. Pharmacokinetic and pharmacodynamic analysis are performed based on plasma
      concentration of sugammadex sodium and monitoring of neuromuscular blockade.
    

Eligibility criteria:

        Inclusion Criteria: All of below

          -  Pediatric patients undergoing surgery under general anesthesia with requirement of
             early reversal of neuromuscular blockade

          -  Aged between 2 and 17

          -  American Society of Anesthesiologists Physical Status Classification 1 and 2

        Exclusion Criteria: Any of below

          -  One or more legal guardian declines to enroll in the study

          -  History of hypersensitivity to any anesthetic agents including rocuronium

          -  Presence of underlying cardiovascular or genitourinary disease

          -  Under usage of neuromuscular blocking agents before surgery

          -  Under usage of drugs influencing the effect of neuromuscular blocking agents

          -  History of malignant hyperthermia

          -  Anticipation of massive hemorrhage during surgery
A Study of Erlotinib [Tarceva] as Monotherapy or Intermittent Dosing With Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer. (TALISMAN)
Condition: Non-Squamous Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: docetaxel; erlotinib [Tarceva]; erlotinib [Tarceva]
Intervention description: 75 mg/m2 intravenously every 3 weeks for 4 cycles; 150 mg/day orally, days 2-16 each 3-week cycle for 4 cycles; 150 mg/day orally thereafter; 150 mg/day orally as monotherapy
Intervention MeSH terms: Docetaxel; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized parallel group study will assess the efficacy and safety of erlotinib
      [Tarceva], as monotherapy or intermittent dosing with docetaxel, in second-line setting in
      former-smoker male patients with advanced or metastatic squamous non-small cell lung cancer.
      Patients will be randomized to receive either Tarceva (150 mg/day orally) as monotherapy or 4
      cycles of docetaxel (75 mg/m2 intravenously every 3 weeks) plus Tarceva (150 mg/day orally,
      days 2-16 each cycle) followed by Tarceva monotherapy. Anticipated time on study treatment is
      until disease progression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male patients, >/=18 years of age

          -  former smoker (smoked >/= 100 cigarettes in his lifetime and quit >12 months before
             enrollment)

          -  locally advanced (stage IIIb), metastatic (stage IV) or recurrent squamous non-small
             cell lung cancer

          -  prior platinum-based therapy for advanced NSCLC

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1

        Exclusion Criteria:

          -  uncontrolled symptomatic central nervous system (CNS) metastases

          -  prior therapy against epidermal growth factor receptor (EGFR)

          -  >1 prior chemotherapy for advanced/metastatic NSCLC

          -  radiotherapy <28 days prior to enrollment

          -  history of melanoma at any time, or another malignancy in the last 5 years except for
             carcinoma in situ of the cervix, basal or squamous cell carcinoma of the skin, or
             surgically cured malignant neoplasias with a disease-free interval of >5 years

          -  not fully treated eye inflammation or infection, or predisposing conditions
A 6 Month Safety Extension Study of MBGS205
Condition: Hypogonadotropic Hypogonadism
MeSH terms: Hypogonadism
Intervention: BGS649
Intervention description: Capsules will be taken weekly for a maximum of 24 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 143.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Hypogonadotropic; hypogonadism; testosterone

Summary:

      Phase IIb, multicentre, double-blind, randomised, placebo-controlled parallel-group 36-week
      study evaluating safety and efficacy of BGS649 in male obese subjects with hypogonadotropic
      hypogonadism (HH)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participating in Study MBGS205 and completion of the 24 week treatment period without
             meeting any discontinuation criteria of Study MBGS205

          -  In opinion of the investigator has been compliant with the requirements of the Study
             MBGS205 protocol.

        Exclusion Criteria:

        -Meeting any of the discontinuation criteria of initial Study MBGS205
Effectiveness of Gabapentin on Chronic Irritability in Neurologically Impaired Children
Condition: Neurologically Impaired; Irritable Mood; Signs and Symptoms, Digestive; Sleeplessness; Chronic Pain
MeSH terms: Sleep Initiation and Maintenance Disorders; Chronic Pain; Signs and Symptoms, Digestive
Intervention: Gabapentin; placebo
Intervention description: The active drug is in a flavored glycerin based solution. The drug will be given orally or through a gastrointestinal tube. Titration up to a stable dose will take 22 days. The total stable dose is 40mg/kg/day. Once 7 days on this dose are finished, children will take 6 days to reduce their dose and begin their 3 day washout period.; The placebo is a glycerin-based clear solution that is flavored similarly to the commercial product. The placebo will be given orally or through a gastrointestinal tube.
Intervention MeSH terms: Gabapentin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 2.0
Sex: All
Minimum age: 1 Month
Maximum age: 16 Years
Healthy volunteers: No
Keywords: chronic irritability; chronic pain; Neurologically impaired; gabapentin

Summary:

      This study is a prospective, randomized, double blind, placebo controlled, crossover clinical
      trial looking at whether gabapentin can provide symptom relief for chronic irritability in
      neurologically impaired children. The investigators hypothesize gabapentin ins beneficial and
      safe for children with chronic irritability that persists despite identification and
      appropriate management of symptom sources.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female

          -  1 month to 16 years of age at enrollment

          -  neurological impairment defined as subnormal (-2 S.D.) motor and/or cognitive ability
             from a variety of etiologies

          -  chronic irritability defined as symptoms suggesting pain to the child's caregiver
             recurrently over a 4-week of greater time period

          -  Subject must have an acceptable surrogate capable of giving consent on the subject's
             behalf

        Exclusion Criteria:

          -  Children with resolved symptoms after treatment of identified sources of pain

          -  Identified potential source of irritability without adequate trial of appropriate
             management

          -  Ketogenic diet

          -  Renal insufficiency or failure

          -  Current treatment with gabapentin or pregabalin for another existing condition.
Dexamethasone Solution for the Treatment of Oral Lichen Planus
Condition: Lichen Planus
MeSH terms: Lichen Planus, Oral; Lichen Planus
Intervention: Dexamethasone
Intervention description: Dexamethasone solution 0.5 mg/mL, rinse for 5 minutes and expectorate
Intervention MeSH terms: Dexamethasone
Phase: Phase 2
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: No
Keywords: Oral lichen planus; Dexamethasone solution

Summary:

      The objective of this single center, 4-week, open label randomized, phase II study is to
      evaluate and characterize the tolerability and clinical effectiveness of dexamethasone
      0.5mg/5ml solution in a mucoadhesive vehicle (Mucolox™) for the treatment of oral lichen
      planus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years and older.

          -  Patients with symptomatic oral lichen planus (worst VAS sensitivity score ≥ 7 over the
             last week).

        Exclusion Criteria:

          -  Patients already on topical or systemic steroids.

          -  Inability to comply with study instructions.

          -  Uncontrolled intercurrent illness or psychiatric illness/social situations that would
             limit compliance with study requirements.

          -  VAS sensitivity score < 7.
Sodium Excretion of LCZ696 in Patients With Hypertension; Heart Failure and Healthy Volunteers
Condition: Hypertension
MeSH terms: Hypertension; Heart Failure
Intervention: LCZ696; Valsartan
Intervention description: 200 mg and 400 mg tablets; 160 mg tablets
Intervention MeSH terms: Valsartan; Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sodium excretion,; LCZ696

Summary:

      Assess mechanism of action of LCZ696 related to sodium excretion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with heart failure: documented NYHA class II-III heart failure

          -  Patients with hypertension: stable hypertensive medication for the preceding 2 months

        Exclusion Criteria:

          -  Women of childbearing potential

          -  History of recent myocardial infarction

          -  History of dialysis or renal transplant

          -  Patients with type 1 diabetes mellitus