bioihbjkbjnl/mcl2 huggingface dataset:
A Safety and Efficacy Study of Bimatoprost in Men With Androgenic Alopecia (AGA)
Condition: Alopecia; Alopecia, Androgenetic; Baldness
MeSH terms: Alopecia; Alopecia Areata
Intervention: Bimatoprost Solution 1; Bimatoprost Solution 2; Bimatoprost Vehicle
Intervention description: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.; Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.; Bimatoprost Vehicle (placebo) applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
Intervention MeSH terms: Bimatoprost; Pharmaceutical Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 244.0
Sex: Male
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: No

Summary:

      This is a safety and efficacy study of bimatoprost in male subjects with androgenic alopecia
      (AGA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Mild to moderate male pattern baldness (androgenic alopecia) with ongoing hair loss
             for at least 1 year

          -  Willingness to maintain same hair style, length and hair color during study

          -  Willingness to have micro-dot-tattoo applied to scalp (Stage 2 only)

        Exclusion Criteria:

          -  Drug or alcohol abuse within 12 months

          -  HIV positive

          -  Received hair transplants or had scalp reductions

          -  Use of hair weaves, hair extensions or wigs within 3 months

          -  Use of minoxidil (oral or topical) and/or low level light treatment "combs" for hair
             growth within the last 6 months, or expected use during the study

          -  Application of topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) to
             scalp within 4 weeks
Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
Condition: Autism Spectrum Disorder (ASD); Autism; Autistic Disorder; Asperger's Disorder; Asperger's; Pediatric Autism; Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Developmental Disabilities; Child Development Disorders, Pervasive; Asperger Syndrome
Intervention: Memantine Hydrochloride (HCl)
Intervention description: During the 6-week double-blind dosing titration/maintenance period, Memantine extended-release 3-mg and 6-mg capsules; oral administration. Dosing was once daily.
During open-label treatment: Memantine extended-release 3mg capsules; oral administration. The maximum target dosage was identified during the prior studies for each patient. Dosing was once daily.
Intervention MeSH terms: Memantine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 747.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Autistic Disorder; Asperger's Disorder; Asperger's; Pediatric Autism; Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS); Pervasive Child Development Disorder

Summary:

      The objective of this study is to evaluate the long-term safety and tolerability of memantine
      in the treatment of pediatric patients with autism, Asperger's Disorder or Pervasive
      Developmental Disorder Not Otherwise Specified (PDD-NOS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who completed Study MEM-MD-67, MEM-MD-68, MEM-MD-91, or discontinued Study
             MEM-MD-68 due to meeting the criterion for loss of therapeutic response.

          -  Having normal results from a physical examination and laboratory tests at Visit 1 of
             this study (last visit of the preceding study). Any abnormal findings must be deemed
             not clinically significant by the Investigator and documented as such.

          -  Have a family that is sufficiently organized and stable to guarantee adequate safety
             monitoring and continuous attendance to clinic visits for the duration of the study

        Exclusion Criteria:

          -  Patients who discontinued a preceding memantine study due to an adverse event possibly
             related to study drug

          -  Patients with a concurrent medical condition that might interfere with the conduct of
             the study, confound interpretation of the study results, or endanger the patient's
             well being

          -  Significant risk of suicidality based on the Investigator's judgment, Aberrant
             Behavior Checklist-irritability subscale (ABC-I), or if appropriate, as indicated by a
             response of "yes" to questions 4 or 5 in the suicidal ideation section of the
             Children's Columbia-Suicide Severity Rating Scale (C-SSRS) or any suicidal behavior
A Study for Participants With Relapsed Cutaneous T-Cell Lymphoma
Condition: Cutaneous T-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous
Intervention: Enzastaurin
Intervention description: 1125 milligrams (mg) loading dose then 500 mg, oral, daily, until disease progression
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to determine the efficacy and safety of enzastaurin in
      participants with Cutaneous T-Cell Lymphoma (CTCL) who failed prior therapies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed mycosis fungoides or Sezary Syndrome.

          -  Stage IB to IVB disease at screening.

          -  Recurrent or refractory disease after at least 1 prior systemic therapy.

          -  Have adequate organ function defined as:

               -  Hepatic: total bilirubin ≤1.5 times the upper limit of normal (ULN); alanine
                  transaminase/aspartate transaminase (ALT/AST) ≤2.5 times the ULN.

               -  Renal: serum creatinine ≤1.5 times the ULN.

               -  Adequate bone marrow reserve: platelets ≥75 * 10^9/Liters (L); absolute
                  neutrophil count (ANC) ≥1.0 * 10^9/L.

          -  At least 30 days must have passed since other treatment for CTCL.

        Exclusion Criteria:

          -  Receiving concurrent treatment for CTCL.

          -  Unable to swallow tablets.

          -  Receiving high potency oral or topical steroids. Low potency oral steroid may be
             permitted in participants who have been on a stable dose for at least 4 weeks prior to
             screening. Oral or topical antihistamine is allowed.

          -  Unable to discontinue use of carbamazepine, phenobarbital, or phenytoin.

          -  Have a serious concomitant systemic disorder or Human Immunodeficiency Virus (HIV).

          -  Have a serious cardiac condition such as myocardial infarction within past 6 months,
             angina, or heart disease as defined by the New York Heart Association (NYHA) Class III
             or IV.

          -  Have electrocardiogram (ECG) abnormalities.

          -  Are pregnant or breastfeeding.
A Study of Management of Tarceva - Induced Rash in Patients With Non-Small Cell Lung Cancer.
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Doxycline; erlotinib [Tarceva]
Intervention description: 100mg po daily; 150mg po daily
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 147.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This 2 arm study will evaluate the management of Tarceva-induced skin rash in patients with
      non-small cell lung cancer who have failed first-line chemotherapy for advanced disease.
      Eligible patients will be randomized to receive a)doxycycline 100mg po daily or b)no
      preventative treatment; all patients will receive Tarceva 150mg/kg po daily. The anticipated
      time on study treatment is until disease progression or intolerable toxicity, and the target
      sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, 18-75 years of age;

          -  confirmed non-small cell lung cancer;

          -  failure after first line chemotherapy for advanced disease, and scheduled for second
             line therapy with Tarceva.

        Exclusion Criteria:

          -  rash of any etiology at study entry;

          -  history of significant heart disease;

          -  any other malignancies (other than adequately treated squamous cell skin cancer, or in
             situ cancer of the cervix);

          -  history of allergic reactions to tetracyclines.
Homoharringtonine (Omacetaxine Mepesuccinate) in Treating Patients With Chronic Myeloid Leukemia (CML) With the T315I BCR-ABL Gene Mutation
Condition: Chronic Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Intervention: Omacetaxine mepesuccinate
Intervention description: Induction:
1.25 mg/m^2 subcutaneously, twice daily for 14 consecutive days every 28 days until response. Patients not demonstrating evidence of clinical response after 6 induction cycles will be considered for removal from the study.
Maintenance:
1.25 mg/m^2 subcutaneously, twice daily for 7 consecutive days in a 28-day cycle, for up to 3 years.
Intervention MeSH terms: Homoharringtonine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Myeloid Leukemia; CML; HHT; Homoharringtonine; Omacetaxine; T315i; ChemGenex; ChemGenex Pharmaceuticals

Summary:

      To evaluate the safety and efficacy of subcutaneous administration of omacetaxine
      mepesuccinate (HHT) in achieving a clinical response in CML patients in chronic, accelerated,
      or blast phase who have failed prior imatinib therapy and have the T315I kinase domain gene
      mutation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients, age 18 years or older

          -  Philadelphia chromosome (Ph) positive chronic myelogenous leukemia in either chronic,
             accelerated, or blast phase

          -  The patient will have the T315I BCR-ABL gene mutation

          -  Patients will have failed prior imatinib therapy

          -  ECOG performance status 0-2

        Exclusion Criteria:

          -  NYHA class III or IV heart disease, active ischemia or any other uncontrolled cardiac
             condition such as angina pectoris, clinically significant cardiac arrhythmia and
             requiring therapy, uncontrolled hypertension or congestive heart failure

          -  Myocardial infarction in the previous 12 weeks

          -  Lymphoid Ph+ blast crisis
A Study to Compare Multiple Doses Intravitreal Microplasmin for Treatment of Patients With Vitreomacular Traction (MIVI-IIt)
Condition: Vitreomacular Traction
Intervention: ocriplasmin; ocriplasmin; Sham Comparator
Intervention description: Intravitreal injection of ocriplasmin solution containing 75µg of ocriplasmin.; Intravitreal injection of ocriplasmin solution containing 125µg of ocriplasmin with up to 2 additional (open label) 125µg ocriplasmin injection at 1 month interval.; Intravitreal sham injection
Intervention MeSH terms: Plasminogen; Fibrinolysin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Vitreomacular Traction; Maculopathy; VMT; PVD

Summary:

      A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical
      PVD induction for treatment of patients with vitreomacular traction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients >_ 18 years of age with vitreomacular traction

        Exclusion Criteria:

          -  PVD present at baseline

          -  Certain vitreoretinal conditions including proliferative disease, rhegmatogenous
             retinal detachment, and proliferative vitreoretinopathy (PVR)

          -  Vitreous hemorrhage

          -  Patients who have had a vitrectomy in the study eye at any time
A Study of Safety and Efficacy of HPN-100 in Subjects With Cirrhosis and Episodic Hepatic Encephalopathy
Condition: Cirrhosis; Hepatic Encephalopathy
MeSH terms: Liver Cirrhosis; Hepatic Encephalopathy; Brain Diseases; Fibrosis
Intervention: HPN-100; Placebo
Intervention description: Part B: 6 mL BID for 16 weeks.; Part B: same as experimental arm
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 189.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cirrhosis; Episodic Hepatic Encephalopathy; HE; HPN-100; GT4P; glycerol phenylbutyrate

Summary:

      This is a phase 2 study of HPN-100 in subjects with hepatic encephalopathy (HE) consisting of
      an open label safety lead-in (Part A), followed by randomized, double-blind,
      placebo-controlled treatment (Part B).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects aged 18 and over

          -  Clinical diagnosis of cirrhosis of any cause

          -  Potential to benefit from HE treatment

          -  History of greater than or equal to 2 documented episodes of WH Grade 2 or more HE
             within the past 6 months, at least one of which occurred within the preceding 3 months

          -  No change in other HE-specific medications within 1 week before randomization

          -  Able to give informed consent and comply with study activities

          -  Availability of at least one designated family member or caregiver who is capable of
             and willing to assume responsibility for facilitating subject compliance with study
             procedures

          -  All females of childbearing age and all sexually active males must agree to use an
             acceptable method of contraception throughout the study.

        Exclusion Criteria:

          -  Use of any investigational drug within 30 days

          -  Use of prohibited medications

          -  Uncontrolled infection

          -  Active GI bleeding or a history of GI bleeding requiring blood transfusion (> 2 units)
             within 3 months

          -  Transjugular intrahepatic portosystemic shunt (TIPS) placement or revision within the
             past 90 days

          -  Recreational drug use or alcohol consumption for subjects with a history of alcohol or
             drug abuse within 6 months

          -  Lactating and/or pregnant females

          -  Active malignancy

          -  Clinically significant bowel disease, including obstruction, inflammatory bowel
             disease, or malabsorption

          -  Expected to undergo transplantation within 6 months

          -  Model for end-stage liver disease (MELD) score of > 25
MemoryXL Effects on Mild Cognitive Impairment Patients
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Intervention: Memory XL; placebo
Intervention description: An over-the-counter vitamin nutriceutical patented by Univ. of Mass. that contains folic acid 400 mg, Vit. B12 6 ug, alpha-tocopherol 30 IU, S-adenosyl methionine (SAM) 400 mg, N-acetyl cysteine (NAC) 600 mg, & acetyl-L-carnitine (ALCAR) 500 mg; 2 pills per day for 12 months; placebo comparator
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 10.0
Sex: All
Minimum age: 55 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Memory XL; Mild Cognitive Impairment; cognitive status

Summary:

      A vitamin nutriceutical, Memory XL, has been shown to provide maintenance of cognitive status
      in mild, moderate, and severe Alzheimer's disease patients (2 publications by T. Shea).
      Because this nutriceutical is now patented by the Univ. of Mass., other trials at that
      institution may be considered a conflict of interest. Therefore, a study of its effects on
      Mild Cognitive Impairment (MCI) patients will be conducted by PI who is not affiliated with
      Univ. of Mass. or with Dr. Shea. The study hypothesis is: Memory XL will maintain or improve
      the cognitive and behavioral status of patients diagnosed with MCI during the year of
      participation in the study; normally, 10-25% of MCI patients convert to mild Alzheimer's
      dementia each year.
    

Eligibility criteria:

        Inclusion Criteria:

          -  MCI patients diagnosed at the VAMC Center for Alzheimers and Neurodegenerative
             Disorder (CANDO).

          -  Clinical Dementia Rating (CDR) score of 0.5.

          -  fluent in English.

          -  able to ambulate to the outpatient clinic and research laboratory

          -  have sight and hearing levels sufficient to complete neuropsychological testing.

          -  free from bipolar disorder and terminal illnesses such as cancer.

          -  must live with a spouse or adult relative who will record nutriceutical ingestion
             daily.

          -  subjects will be consecutively diagnosed patients from all ethnic groups.

        Exclusion Criteria:

          -  patients from protected categories such as prisoners and pregnant women.

          -  any MCI subject who develops a life-threatening disease such as terminal cancer,
             stroke, brain trauma, debilitating heart attack, etc.

          -  indication of inability to make decisions regarding study participation.
Safety and Efficacy of KPI-121 in Subjects With Inflammatory Meibomian Gland Disease
Condition: Blepharitis
MeSH terms: Blepharitis; Meibomian Gland Dysfunction
Intervention: KPI-121; Vehicle
Intervention description: KPI-121 drug product will be supplied in 0.25% strength as a suspension in opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate. Subjects randomized to placebo control arm will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.; The vehicle control has the same composition as KPI-121 0.25% ophthalmic suspension except it does not contain loteprednol etabonate. The vehicle is essentially isotonic and is buffered to maintain pH 5.0 - 7.0. It is a sterile, aqueous solution supplied in the same white, low-density polyethylene plastic dropper bottle with the same white, controlled-drop polyethylene tip and white polypropylene closure as KPI-121 0.25% ophthalmic suspension.
Intervention MeSH terms: Loteprednol Etabonate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 206.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pain; Corticosteroid; Meibomian Gland Disease; Blepharitis; Eyelid; Ocular Discomfort

Summary:

      The primary purpose of this study is to determine the efficacy and safety of KPI-121
      ophthalmic suspension compared to vehicle (placebo) in subjects with signs and symptoms of
      inflammatory meibomian gland disease.
    

Eligibility criteria:

        Inclusion Criteria:

        Have a documented clinical diagnosis of inflammatory meibomian gland disease in both eyes.

        Exclusion Criteria:

          -  Known hypersensitivity/contraindication to study product(s) or components.

          -  Be currently receiving treatment for glaucoma, have history of or current glaucoma, or
             an IOP (intraocular pressure) over 21mmHg at Visit 1 (Screening) or Visit 2
             (Randomization).

          -  Be unwilling to discontinue warm compress therapy, lid expression, or lid massage 14
             days prior to Day 1 and for the duration of the study.

          -  Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in
             judgment of Investigator could confound study assessments or limit compliance;
             severe/serious systemic disease or uncontrolled medical condition that in judgment of
             Investigator could confound study assessments or limit compliance; or have been
             exposed to an investigational drug within the 30 days prior to screening.

          -  Have had ocular surgery in the past 90 days or require ocular surgery during the
             study.

          -  In the opinion of Investigator or study coordinator, be unwilling or unable to comply
             with study protocol or unable to successfully instill eye drops.