bioihbjkbjnl/mcl2 huggingface dataset:
A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy
Condition: Narcolepsy
MeSH terms: Narcolepsy; Disorders of Excessive Somnolence; Sleepiness
Intervention: ADX-N05; Placebo
Intervention description: 150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks; One capsule placebo to match ADX-N05 to be taken for 4 weeks followed by 2 capsules placebo to match ADX-N05 to be taken for 8 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This is a study to evaluate the safety and effectiveness of ADX-N05 compared to placebo in
      the treatment of excessive daytime sleepiness in adults with narcolepsy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of narcolepsy

          -  Good general health

          -  Willing and able to comply with the study design and schedule and other requirements

        Exclusion Criteria:

          -  If female, pregnant or lactating

          -  Customary bedtime later than midnight

          -  History of significant medical condition, behavioral, or psychiatric disorder
             (including suicidal ideation), or surgical history

          -  Any other clinically relevant medical, behavioral or psychiatric disorder other than
             narcolepsy that is associated with excessive sleepiness

          -  History of significant cardiovascular disease

          -  Body mass index > 34

          -  Excessive caffeine use - > 600 mg/day of caffeine or > 6 cups of coffee/day

          -  History of alcohol or drug abuse within the past 2 years

          -  Nicotine dependence that has an effect on sleep
68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Biopsy Guidance in Patients With Suspected Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: 68Ga RM2; 68Ga-PSMA-11; Investigational PET scanner coils and software
Intervention description: PET radiopharmaceutical; PET radiopharmaceutical; GE Healthcare non-approved PET scanner coils and software
Intervention MeSH terms: Gallium 68 PSMA-11; Bombesin
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate Cancer

Summary:

      The objective of the study is to evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for
      biopsy guidance in patients with suspected prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Suspected prostate cancer

          -  Planned prostate biopsy

          -  Able to provide written consent

          -  Karnofsky performance status of 50 (or ECOG/WHO equivalent)

        Exclusion Criteria:

          -  Patients not capable of getting PET study due to weight, claustrophobia, or inability
             to lay still for the duration of the exam

          -  Metallic implants (contraindicated for MRI)
An Investigational Immunotherapy Study of Nivolumab in Combination With Rucaparib, Docetaxel, or Enzalutamide in Metastatic Castration-resistant Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: nivolumab; docetaxel; enzalutamide; rucaparib; prednisone
Intervention description: Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Prednisone; Docetaxel; Nivolumab; Rucaparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 292.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety and efficacy of nivolumab in combination
      with rucaparib, docetaxel, or enzalutamide in participants with castration-resistant prostate
      cancer that has spread.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic confirmation of adenocarcinoma of the prostate

          -  Evidence of stage IV disease on previous bone, CT, and/or MRI scan

          -  Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone
             (GnRH) analogue or bilateral orchiectomy

          -  Mandatory plasma and fresh or archival tumor tissue must be submitted

        Exclusion Criteria:

          -  Prior malignancy active within the previous 3 years except for locally curable cancers
             that have been apparently cured, such as basal or squamous cell skin cancer,
             superficial bladder cancer, or carcinoma in situ of the breast

          -  Participants with active brain metastases

          -  Participants must have recovered from the effects of major surgery requiring general
             anesthesia or significant traumatic injury at least 14 days before treatment arm
             assignment

        Other protocol defined inclusion/exclusion criteria could apply
Botulinum Toxin Type A (BOTOX®) Treatment of Masseter Muscle Hypertrophy
Condition: Masseter Muscle Hypertrophy
MeSH terms: Hypertrophy
Intervention: botulinum toxin Type A; Normal saline
Intervention description: Botulinum toxin Type A (BOTOX®) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.; Normal saline (placebo) administered intramuscularly to the bilateral masseter muscles.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 187.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of a range of doses of botulinum toxin Type
      A (BOTOX®) for the treatment of patients with bilateral Masseter Muscle Hypertrophy (MMH).
    

Eligibility criteria:

        Inclusion Criteria:

        -Participants with Masseter Muscle Hypertrophy

        Exclusion Criteria:

          -  Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis,
             or any other condition that might interfere with neuromuscular function

          -  Prior botulinum toxin treatment of any serotype to the masseter muscle or lower face

          -  History of dental or surgical procedure for lower facial shaping or masseter muscle
             reduction

          -  History of or current temporomandibular joint disorder (TMJD)
Imaging Characteristics of a Follow-up 18F-AV-1451 Scan
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Flortaucipir F18; Florbetapir F 18; Brain PET Scan
Intervention description: 370 megabecquerel (MBq) IV single-dose; 370 megabecquerel (MBq) IV single-dose; positron emission tomography (PET) scan of the brain
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the imaging characteristics of flortaucipir in subjects with a
      previous flortaucipir scan in order to assess the rate of change of tau deposition over time.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a previous 18F-AV-1451 brain scan

          -  Can tolerate up to two Positron Emission Tomography (PET) imaging sessions and a
             Magnetic Resonance Imaging (MRI) scan

          -  Ability to provide informed consent

        Exclusion Criteria:

          -  Current clinically significant psychiatric disease

          -  Are claustrophobic

          -  Current clinically significant cardiovascular disease or ECG abnormalities, or
             additional risk factors for Torsades de Pointes

          -  Current clinically significant infectious disease, endocrine or metabolic disease,
             pulmonary, renal or hepatic impairment, or cancer

          -  Females of childbearing potential who are not surgically sterile, not refraining from
             sexual activity or not using reliable methods of contraception

          -  Have had a non-study related radiopharmaceutical imaging or treatment procedure within
             7 days prior to the study imaging session
A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Arthritis
Condition: Lupus Arthritis
MeSH terms: Arthritis; Lupus Erythematosus, Systemic
Intervention: Laquinimod; Placebo
Intervention description: Laquinimod will be administered per dose and schedule specified in the arm description.; Placebo matching to laquinimod will be administered per schedule specified in the arm description.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 82.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Systemic Lupus Erythematosus (SLE); Lupus Arthritis; Laquinimod

Summary:

      The study aims to evaluate the safety and clinical effect of daily oral treatment with
      laquinimod capsules (0.5 milligrams [mg] and 1 mg) in participants with active lupus
      arthritis. Laquinimod is a novel immunomodulating drug which is currently in advanced stages
      of development by Teva Pharmaceuticals Ltd. for Multiple Sclerosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants diagnosed with SLE.

          -  Participants with active lupus arthritis as evident by at least 4 tender and 4 swollen
             joints at screening and baseline visits, and moderate or severe arthritis with active
             synovitis in at least 1 joint, with some loss of functional range of movement present
             at screening and baseline visits.

        Exclusion Criteria:

          -  The participant's estimated glomerular filtration rate (eGFR) was less than or equal
             to 30 milliliters (mL)/minute/1.73 square meter (m^2), as calculated by the
             Modification of Diet in Renal Disease (MDRD) formula at the screening visit.

          -  Participants with severe, unstable and/or progressive central nervous system (CNS)
             lupus and/or associated with significant cognitive impairment (upon the investigators'
             judgement).

          -  Participants with a clinically significant or unstable medical or surgical condition
             that, in the investigator's opinion, would preclude safe and complete study
             participation.

          -  Women who are pregnant or nursing or who intend to be during the study period.

          -  Women of child-bearing potential who do not practice an acceptable method of birth
             control.
A Clinical Trial of Intravenous (IV) Ganaxolone in Women With Postpartum Depression
Condition: Depression; Depressive Disorder; Depression, Postpartum; Behavioral Symptoms; Mood Disorders; Mental Disorders; Puerperal Disorders; Pregnancy Complications; Postpartum; PPD
MeSH terms: Depression, Postpartum; Pregnancy Complications; Puerperal Disorders; Depression; Depressive Disorder; Mental Disorders; Mood Disorders; Behavioral Symptoms
Intervention: Ganaxolone; Placebo
Intervention description: Ganaxolone IV; Placebo IV
Intervention MeSH terms: Ganaxolone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 91.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Postpartum Care; Postpartum Depression

Summary:

      This study will evaluate the Safety, Pharmacokinetics and Efficacy of IV Administration of
      Ganaxolone in Women with Postpartum Depression
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant experienced a Major Depressive Episode, which started between the start of
             the third trimester and 4 weeks following delivery. The Major Depressive Episode must
             be diagnosed according to Mini International Neuropsychiatric Interview (MINI) 7.0
             interview

          -  Participant gave birth in the last 6 months

          -  Participant has a Hamilton Depression Rating Scale 17-item version (HAMD17) score of ≥
             26 at screening

          -  Participant must agree to stop breastfeeding from start of study treatment or must
             agree to temporarily cease giving breast milk to her infant(s)

        Exclusion Criteria:

          -  Current or past history of any psychotic illness, including Major Depressive Episode
             with psychotic features

          -  History of suicide attempt within the past 3 years

          -  Active suicidal ideation

          -  History of bipolar I disorder

          -  History of seizure disorder
Efficacy, Safety and Pharmacokinetics of Topical Timolol in Infants With Infantile Hemangioma (IH)
Condition: Infantile Hemangioma
MeSH terms: Hemangioma; Hemangioma, Capillary; Port-Wine Stain
Intervention: 0.25% Timolol Maleate Gel Forming Solution; 0.5% Timolol Maleate Gel Forming Solution
Intervention description: 50:50 Randomized 0.25% Timolol Maleate Gel Forming Solution; 50:50 Randomized 0.5% Timolol Maleate Gel Forming Solution
Intervention MeSH terms: Timolol; Pharmaceutical Solutions; Maleic acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 105.0
Sex: All
Maximum age: 84 Days
Healthy volunteers: No
Keywords: Hemangioma; Infantile Hemangioma; Pharmacokinetics

Summary:

      The purpose of this study is to assess the safety and efficacy of Timolol 0.25% and 0.5%
      doses.
    

Eligibility criteria:

        Inclusion Criteria

          1. Documented informed consent from legal guardian

          2. 0-84 days postnatal age at time of first study dose or when enrolled into the
             non-intervention cohort.

          3. Clinical diagnosis of superficial cutaneous or mucosal infantile hemangioma (must
             include all of the following):

               1. Superficial lesion in the dermis

               2. Thin <2 mm in thickness

               3. Small >=5 cm at its longest dimension and <=10cm2

               4. Involves skin or keratinized mucosa

        Exclusion Criteria

          1. History of previous treatment with any pharmacologic or laser therapy for IH

          2. Ongoing therapy with an oral beta blocker or oral corticosteroid (e.g., cardiac
             arrhythmia, adrenal insufficiency, upper airway obstruction, tetralogy of fallot
             (TOF), hypertension, reactive airways disease)

          3. IH that requires systemic therapy (defined by dynamic complication scale >3)

          4. IH of the non-keratinized mucosa

          5. Infants with more than one hemangioma that requires therapy

          6. Hemodynamically significant cardiovascular disease, as determined by the investigator

          7. Known allergy to beta blockers or vehicle

          8. Heart rate <100 beats per minute at screening visit

          9. Known prenatal or postnatal diagnosis of 2nd/3rd degree atrioventricular block

         10. History of Reactive Airways Disease (RAD)

         11. Any condition which would make the participant, in the opinion of the investigator
             unsuitable for the study.
High Dose Intravenous Thiamine for the Prevention of Delirium in Allogeneic Hematopoietic Stem Cell Transplantation
Condition: Hematopoietic Stem Cell Transplantation; Delirium; Thiamine Deficiency
MeSH terms: Delirium; Thiamine Deficiency; Beriberi
Intervention: Thiamine; Normal saline
Intervention description: 200 mg IV three times daily for seven days; Normal saline IV three times daily for seven days
Intervention MeSH terms: Thiamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Purpose: To conduct a randomized controlled pilot study investigating the use of high dose
      intravenous (IV) thiamine to prevent delirium and mitigate the long-term effects of delirium,
      including health-related quality of life (HRQOL), functional status, and neuropsychiatric
      outcomes, in patients admitted to University of North Carolina (UNC) Hospital for allogeneic
      hematopoietic stem cell transplant (HSCT).

      Participants: 60 adult inpatients admitted to the UNC Bone Marrow Transplant Unit for
      allogeneic stem cell transplant.

      Procedures (methods): Participants will be admitted for allogeneic HSCT and on the day after
      transplant randomized to seven days of high dose IV thiamine or placebo. Thiamine levels will
      be measured weekly and participants will be assessed for evidence of delirium using validated
      measures. Validated measures will also be used to assess cognitive function, depression,
      post-traumatic stress symptoms, functional status, and HRQOL prior to hospitalization and at
      one, three, and six months after transplant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Admission to the UNC Hospital Bone Marrow Transplant Unit for allogeneic stem cell
             transplant

          -  At least 18 years of age

          -  Able to speak English

          -  Able to provide informed consent

        Exclusion Criteria:

          -  A history of adverse reaction to IV thiamine

          -  Pregnancy, confirmed by a negative pregnancy test within 30 days of study enrollment
Explorative Trial Evaluating the Efficacy and Tolerability of LEO43204 in Moderate to Severe Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: LEO43204; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: No

Summary:

      An exploratory Phase 2, single, centre, prospective, randomized, placebo-controlled,
      double-blinded, split-pace (left/right) design trial to evaluate the efficacy and
      tolerability of LEO 43204 in adults with moderate to severe acne.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects should be diagnosed with acne vulgaris of the face

          -  Fitzpatrick skin types I-III (due to lack of safety data for the investigational
             product in darker skin types)

          -  Disease severity and total lesion count should be similar in both TAs

          -  Disease severity grade as moderate to severe according to the investigator's global
             assessment (grade 3-4)

          -  Age 18 to 35 years incl.

          -  Male or female

          -  Female Subjects must be of either non-childbearing potential or child-bearing
             potential with a confirmed negative pregnancy test

        Exclusion Criteria:

          -  Subjects with nodulocystic acne, acne conglobata, acne fulminans, secondary acne (e.g.
             chlor-acne, drug-induced acne)

          -  Subjects with previous history of keloid formation or post-inflammatory
             hyperpigmentation

          -  Systemic retinoids within 12 month or systemic antibiotics within 1 month before Day 1

          -  Topical retinoids within 3 months before Day 1 or other topical treatments and/or
             medicated products and cosmetics that in the opinion of the investigator may influence
             the subjects acne vulgaris (including soaps containing antibacterial agents such as
             benzoyl peroxide, keratinolytic agents such as salicylic acid, skin
             fresheners/astringents or aftershave products) within 1 month before Day 1
Sphenopalatine Ganglion Block for Headache After Concussion
Condition: Concussion; Headache
MeSH terms: Ganglion Cysts; Headache
Intervention: Lidocaine in SphenoCath device; Saline Solution in SphenoCath device
Intervention description: Participants will receive 2.5 cc of lidocaine 1% solution intranasally via a SphenoCath device into each nares.The portion of the procedure involving this device lasts approximately 30-60 seconds.; Participants will receive saline solution via a SphenoCath device into each nares. The portion of the procedure involving this device lasts approximately 30-60 seconds.
Intervention MeSH terms: Lidocaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Concussions; headaches; sphenopalatine ganglion block

Summary:

      This clinical trial will enroll participants to evaluate the effects of SPG block on
      post-traumatic headache. The study hypothesizes that patients that receive a SPG block with
      lidocaine vs. placebo (saline) will have a lower number of headache days in the week
      following the procedure, and will also report lower symptom scores.

      Eligible participants will receive one treatment (SPG block) as well as complete surveys
      prior to and after receiving treatment (for a total of approximately 2 weeks).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with a concussion and are greater than 14 days from the date of their
             injury.

          -  Experiencing greater or equal than 4 occurrences of headache per week lasting at least
             1 hour per occurrence with a headache severity score greater or equal to 2 out of 6.

        Exclusion Criteria:

          -  Allergy to local anesthetics of the amide type (for example (i.e.) lidocaine)

          -  Frequent epistaxis (i.e. more than one nose bleed per month),

          -  Bleeding disorders

          -  History of any of the following: nasal or facial fracture, nasal septal defect, any
             other craniofacial abnormality, hepatic disease, Adam-Stokes syndrome,
             Wolff-Parkinson-White syndrome, or severe degrees of sinoatrial, atrioventricular, or
             intraventricular heart block

          -  Pregnant

          -  Are at increased risk for methemoglobinemia (including patients with
             glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic
             methemoglobinemia, cardiac or pulmonary compromise, and concurrent exposure to
             oxidizing agents or their metabolites and drugs associated with methemoglobinemia)