bioihbjkbjnl/mcl2 huggingface dataset:
Memantine in Body Focused Repetitive Behaviors
Condition: Trichotillomania (Hair-Pulling Disorder); Dermatillomania
MeSH terms: Trichotillomania
Intervention: Placebo; Memantine
Intervention description: Pill that contains no medicine; Cognition-enhancing medication
Intervention MeSH terms: Memantine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is 8 weeks long and involves subjects taking memantine or placebo. If they are
      randomly assigned to the memantine arm and are eligible to participate in the study, they
      will begin by taking 10mg once daily of memantine for two weeks, then 20mg for the remaining
      six weeks. Efficacy and safety measures will be performed at each visit. Participants will be
      randomized to receive either memantine or placebo on a 1:1 basis. This blinding will be
      maintained by the IDS pharmacy at the University of Chicago.
    

Eligibility criteria:

        Inclusion Criteria:

          1. men and women age ≥18 years;

          2. current DSM-5 trichotillomania or skin picking disorder; and

          3. Ability to understand and sign the consent form.

        Exclusion Criteria:

          1. Unstable medical illness based on history or clinically significant abnormalities on
             baseline physical examination

          2. Current pregnancy or lactation, or inadequate contraception in women of childbearing
             potential

          3. Subjects considered an immediate suicide risk based on the Columbia Suicide Severity
             rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs)

          4. Past 12-month DSM-5 diagnosis of psychosis, bipolar disorder, mania, or a substance or
             alcohol use disorder

          5. Illegal substance use based on urine toxicology screening

          6. Stable dose of medications for at least the past 3 months

          7. Previous treatment with memantine

          8. Cognitive impairment that interferes with the capacity to understand and
             self-administer medication or provide written informed consent
A Study of LY900014 in a Medtronic Pump
Condition: Type1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Intervention: LY900014; Insulin Lispro
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Insulin Lispro
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the study drug LY900014 to insulin lispro (Humalog)
      when both are delivered by the Medtronic MiniMed 670G System in adults with type 1 diabetes
      (T1D). The study will consist of two treatment periods of 4 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have been diagnosed with type 1 diabetes and have been using insulin
             continuously for at least 12 months

          -  Participants must be using an insulin pump with "rapid-acting insulin" for at least 6
             months and the same "rapid acting insulin" for at least the past 30 days

          -  Participants must have hemoglobin A1c (HbA1c) values ≥6.0% and ≤8.0%

          -  Participants must have been using the MiniMed 670G insulin pump for at least the past
             90 days

          -  Participants must use their Guardian (3) sensor at least an average of 75% of the time
             and remain in Auto Mode an average of 70% of the time

        Exclusion Criteria:

          -  Participants must not have had more than 1 emergency treatment for very low blood
             glucose or any hospitalizations for poor glucose control (very high blood sugar or
             diabetic ketoacidosis) in the last 6 months

          -  Participants must not have significant abnormal accumulation of fat, loss of fat
             tissue, or scars just under the skin in areas of infusion or have a history of an
             infection at an infusion site within 90 days prior to screening

          -  Participants must not have a total daily insulin dose >100 units

          -  Participants must not be receiving any oral or injectable medication intended for the
             treatment of diabetes other than rapid-acting analog insulin via CSII in the 30 days
             prior to screening

          -  Participants must not have major problems with their heart, kidneys, liver, or have a
             blood disorder
Antioxidation Medication for Noise-induced Hearing Loss
Condition: Hearing Loss
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Noise-Induced
Intervention: N-acetylcysteine (NAC); glucose
Intervention description: 600mg twice daily for 2 weeks; 1 gm glucose capsule
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 53.0
Sex: Male
Minimum age: 25 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: noise; hearing loss; temporary threshold shift

Summary:

      This study will examine whether oral intake of 1200mg N-Acetylcysteine/day will prevent
      temporary threshold shift in hearing among workers exposed to noise
    

Eligibility criteria:

        Inclusion Criteria:

          -  workers in steel industry

          -  known exposure to noise at work

        Exclusion Criteria:

          -  ever diagnosed as having diabetes mellitus

          -  fasting glucose of 120 or greater
A Study of Atezolizumab in Participants With Programmed Death - Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Atezolizumab
Intervention description: 1200 mg IV every 3 weeks
Intervention MeSH terms: Atezolizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 667.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This multicenter, single-arm study will evaluate the efficacy and safety of Atezolizumab in
      participants with PD-L1-positive locally advanced or metastatic non-small cell lung cancer
      (NSCLC). Participants will receive Atezolizumab 1200 milligrams (mg) intravenously every 3
      weeks as long as participants are experiencing clinical benefit as assessed by the
      investigator, that is , in the absence of unacceptable toxicity or symptomatic deterioration
      attributed to disease progression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult participants greater than or equal to 18 years of age

          -  Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) NSCLC

          -  Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens

          -  PD-L1-positive tumor status as determined by an immunohistochemistry (IHC) assay based
             on PD-L1 expression on tumor infiltrating immune cells and/or tumor cells performed by
             a central laboratory

          -  Measurable disease, as defined by RECIST version 1.1

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

        Exclusion Criteria:

          -  Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3
             weeks prior to initiation of study treatment; the following exception are allowed:

        Hormone-replacement therapy or oral contraceptives tyrosine-kinase inhibitors (TKIs)
        approved for treatment of NSCLC discontinued >7 days prior to Cycle 1, Day 1

          -  Central nervous system (CNS) disease, including treated brain metastases

          -  Malignancies other than NSCLC within 5 years prior to randomization, with the
             exception of those with negligible risk of metastases or death and treated with
             expected curative outcome

          -  History of autoimmune disease

          -  History of idiopathic pulmonary fibrosis (including pneumonia), drug-induced
             pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening CT
             scan. History of radiation pneumonitis in the radiation field (fibrosis) id permitted

          -  Active hepatitis B or hepatitis C

          -  Human Immunodeficiency virus (HIV) positive

          -  Prior treatment with CD137 agonists, anti-CTLA4, anti-PD-1, or anti-PD-L1 therapeutic
             antibody or pathway-targeting agents
A Study of Topical NS2 Cream to Treat Ichthyosis in Sjögren-Larsson Syndrome (SLS)
Condition: Sjögren-Larsson Syndrome
MeSH terms: Sjogren's Syndrome; Ichthyosis; Sjogren-Larsson Syndrome; Syndrome
Intervention: Active topical NS2 1% dermatologic cream; Vehicle placebo 0.0% NS2 dermatologic cream
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No
Keywords: Sjögren-Larsson Syndrome; SLS; FALDH Deficiency; Neuro-ichthyosis; Fatty Alcohol:NAD+ Oxidoreductase Deficiency; Fatty Aldehyde Dehydrogenase Deficiency Disease; Congenital Icthyosis Mental Retardation Spasticity Syndrome; Spastic Neurologic Disorder; Oligophrenia; Ichthyosis

Summary:

      This is a multi-center, randomized, double-blind, vehicle-controlled, parallel-group study
      designed to evaluate the safety, pharmacokinetic (PK), and exploratory activity of
      topically-applied NS2 dermatologic cream administered once-daily (QD) to subjects with
      ichthyosis secondary to Sjögren- Larsson Syndrome (SLS).

      NS2 is expected to trap fatty aldehydes that are pathogenic in SLS patients, and thereby
      diminish the lipid-aldehyde adduct formation that likely results in ichthyosis associated
      with SLS, and potentially reduce the mild dermal inflammation characteristic of SLS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Genetically-confirmed diagnosis of SLS

          -  Active ichthyosis on the lower extremities that is determined to be at least moderate
             severity

        Exclusion Criteria:

          -  Evidence of an active infection

          -  Currently receiving immunosuppressive therapy, including intermittent or low-dose
             corticosteroids and is not able or willing to suspend from 2 weeks before and during
             the study

          -  Currently receiving systemic or topical retinoids, other topically applied drugs, or
             other supplements that could interfere with dermatologic examination findings

          -  Received an investigational systemic or topically administered drug within 30 days
             before screening
Study of Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Children With Autism
Condition: Autism
MeSH terms: Autistic Disorder
Intervention: Memantine - Extended Release (ER); Placebo
Intervention description: Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.; Placebo capsules, once daily, oral administration.
Intervention MeSH terms: Memantine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 124.0
Sex: All
Minimum age: 6 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: autism; memantine; pediatric; Forest Laboratories; Autism in pediatric patients

Summary:

      The purpose of this study is to investigate the safety and efficacy of memantine extended
      release, as well as its extent of absorption in pediatric patients with autism.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females ages 6 to 12 years

          -  Diagnosis of autistic disorder, according to DSM-IV-TR using Autism Diagnostic
             Interview-Revised and Autism Diagnostic Observation Schedule (modules 2 & 3).

          -  A knowledgeable caregiver capable of providing reliable information about the
             patient's condition, able to attend all clinic visits with the patient

          -  Patients over age 12, only if they completed Study MEM-PK-21

        Exclusion Criteria:

          -  Medical history of active epilepsy/seizure disorder except simple febrile seizures

          -  Participation in any other clinical investigation using an experimental drug within 30
             days of the start of this study
Clinical Trial of the "Living Well With Hearing Loss Workshop"
Condition: Hearing Loss; Stress
MeSH terms: Hearing Loss; Deafness
Intervention: The Living Well with Hearing Loss Workshop; hearing aid services
Intervention description: Interactive group session modeled on Patient-Centered medicine and Adult Learning principles; the participants are partners with the Group Facilitator who is a hearing rehabilitation professional; Standard VA audiological hearing aid dispensing services
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Audiology; Coping behaviors; Counseling; Hearing aids; Hearing impairment; Patient-centered care; Psychological adaptation; Psychological adjustment; Rehabilitation; Social adjustment; Aural Rehabilitation

Summary:

      This study evaluates whether a 2 hour group session, "The Living Well with Hearing Loss
      Workshop," can successfully teach hard of hearing people how to best use hearing aids and a
      variety of personal skills to compensate for the limitations of their impaired ears.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects are users of new hearing aids with mild to severe hearing loss in better ear.

        Exclusion Criteria:

          -  Patient has been in aural rehabilitation in the past 2 years, or has a condition
             besides hearing loss that affects age-appropriate social activity.
Zalutumumab in Combination With Chemo-Radiation in a Certain Type of Lung Cancer
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Zalutumumab; Induction chemotherapy; Radiotherapy
Intervention description: 8 mg/kg; Combination of cisplatin and docetaxel administered as two cycles given every three weeks; 64 Gy in 32 fractions over 6.5 weeks
Intervention MeSH terms: Zalutumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to investigate if treatment with zalutumumab in combination with
      chemotherapy and radiotherapy (chemo-radiation) will lead to a prolonged life in patients
      with lung cancer compared to patients treated with chemo-radiation alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  NSCLC stage IIIA-IIIB

          -  Performance status 0 or 1 (Zubrod or WHO Scale)

        Exclusion Criteria:

          -  Evidence of metastases either in a separate lobe of the lung, or extra thoracic

          -  Patients with high risk of radiation pneumonitis and or compromised lung function

          -  Estimated life expectancy of less than 3 months

          -  Prior chemotherapy for lung cancer

          -  Prior radiotherapy to the chest

          -  Prior surgery with curative intent for lung cancer
Exploratory Study for Dry Mouth in Patients With Sjögren's Syndrome
Condition: Xerostomia; Sjogren's Syndrome
MeSH terms: Sjogren's Syndrome; Xerostomia; Syndrome
Intervention: Rebamipide
Intervention MeSH terms: Rebamipide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 104.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to exploratively investigate the clinical efficacy of rebamipide
      on dry mouth in patients with Sjögren's syndrome in comparison with placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with Sjögren's syndrome (Revised Japanese criteria for Sjögren's syndrome
             (1999): 1998 research report on immunological intractable diseases specified by the
             Japanese Ministry of Health and Welfare)

          2. Patients aged 20 years or older at time of consent

          3. Patients with dry mouth

          4. Patients with decreased salivation

        Exclusion Criteria:

          1. Patients who have developed dry mouth clearly due to a cause other than Sjögren's
             syndrome

          2. Patients in whom Saxon test cannot be performed (artificial tooth, tooth implant,
             etc.)

          3. Patients who have received rebamipide within 3 months prior to obtaining informed
             consent

          4. Patients who are pregnant, possibly pregnant, or lactating

          5. Patients with a history of hypersensitivity to rebamipide

          6. Patients who have received any other investigational drug within 3 months prior to
             obtaining informed consent

          7. Patients who are otherwise judged inappropriate for inclusion in the study by the
             investigator or subinvestigator
An Efficacy Study in Gastric and Gastroesophageal Junction Cancer Comparing Ipilimumab Versus Standard of Care Immediately Following First Line Chemotherapy
Condition: Locally Advanced (Unresectable) or Metastatic Adenocarcinoma of the Gastric and Gastro-esophageal Junction
MeSH terms: Adenocarcinoma
Intervention: Ipilimumab; Best Supportive care (BSC)
Intervention MeSH terms: Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 143.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to compare the efficacy of Ipilimumab and standard of care as
      sequential or maintenance treatment immediately after first-line chemotherapy in the
      treatment of unresectable or metastatic gastric and gastro-esophageal cancer.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com.

        Key Inclusion Criteria:

          -  Histologically confirmed, unresectable locally advanced or metastatic adenocarcinoma
             of the gastric and gastro-esophageal junction

          -  Received first-line chemotherapy using fluoropyrimidine and platinum combination
             without disease progression

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Measurable disease by modified WHO criteria (unless complete response from previous
             chemotherapy)

        Key Exclusion Criteria:

          -  Known Human Epidermal growth factor Receptor2 (HER2) positive status

          -  Radiological evidence of brain metastases

          -  History of severe autoimmune or immune mediated disease requiring prolonged
             immunosuppressive treatment

          -  Inadequate hematologic, renal and hepatic function
A Study of E7080 in Subjects With Advanced Thyroid Cancer
Condition: Thyroid Cancer
MeSH terms: Thyroid Neoplasms; Thyroid Diseases
Intervention: E7080 capsule
Intervention description: E7080 is administered as continuous once daily dosing in an uncontrolled manner
Intervention MeSH terms: Lenvatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Thyroid cancer

Summary:

      This study is to evaluate the safety, efficacy, and pharmacokinetics of E7080 when orally
      administered once daily (QD) in subjects with advanced thyroid cancer.
    

Eligibility criteria:

        Inclusion criteria

          1. Histologically or clinically diagnosed with thyroid cancer

          2. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 0-2

          3. Adequate laboratory values/organ function tests

        Exclusion criteria

        Participants with following complication or disease history

          1. Brain metastasis

          2. Systemic severe infection

          3. Significant cardiovascular impairment

          4. QTc greater than 480 milliseconds

          5. Active hemoptysis

          6. Bleeding or thrombotic disorders

          7. Having greater than 1+ proteinuria on urine dipstick testing will undergo 24 hour
             urine collection for quantitative assessment of proteinuria

          8. Gastrointestinal malabsorption or any other condition in the opinion of the
             investigator that might affect the absorption of E7080

          9. Major surgery within 3 weeks before enrollment

         10. With co-existing effusion requiring drainage
Randomized Study Comparing Genz-644470, Placebo, and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis
Condition: Kidney Failure, Chronic
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Failure, Chronic
Intervention: Placebo; Genz-644470; Sevelamer carbonate
Intervention MeSH terms: Sevelamer
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 349.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Kidney Disease; Phosphate Binder; Phosphate; Hyperphosphatemia

Summary:

      The purpose of this clinical study is to compare the effects of Genz-644470 with the effects
      of placebo and sevelamer carbonate (Renvela®) on the reduction of serum phosphorus in
      hyperphosphatemic chronic kidney disease participants on hemodialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Serum phosphate level greater than (>) 5.5 milligram per deciliter (mg/dL) (1.78
             millimole per liter [mmol/L]) after discontinuation of current phosphate binder
             therapy

          -  Men or women 18 years or older

        Exclusion Criteria:

          -  Have active dysphagia or swallowing disorder or a predisposition to or current bowel
             obstruction, ileus, or severe gastrointestinal motility disorders including severe
             constipation