bioihbjkbjnl/mcl2 huggingface dataset:
Phase 2 Trial of a Nicotinic Agonist in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Placebo; 3-(2,4 dimethoxybenzylidene anabaseine) 150 mg; 3-(2,4 dimethoxybenzylidene anabaseine) 75 mg
Intervention description: Placebo by mouth twice a day for 4 weeks; 3-(2,4 dimethoxybenzylidene) 150 mg by mouth twice a day for 4 weeks; 3-(2,4 dimethoxybenzylidene) 75 mg by mouth twice a day for 4 weeks
Intervention MeSH terms: 3-(2,4-dimethoxybenzylidene)anabaseine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizophrenia

Summary:

      The study hypothesis is that 3-2,4 dimethoxybenzylidene anabaseine (DMXB-A), an orally
      administered nicotinic cholinergic agonist, will improve attention and other
      neuropsychological dysfunctions in schizophrenia, leading to improved psychosocial outcome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Schizophrenia

          -  Currently treated with neuroleptic drugs

        Exclusion Criteria:

          -  Treatment with clozapine;

          -  Head injury or neurological condition;

          -  Cardiovascular disease;

          -  Substance abuse or dependence, including nicotine
Does Doxazosin Attenuate Stress-induced Smoking and Improve Clinical Outcomes?
Condition: Smoking
Intervention: Doxazosin 4mg/day; Placebo; Doxazosin 8mg/day
Intervention description: 4 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.; Placebo; 8 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.
Intervention MeSH terms: Doxazosin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: smoking lapse behavior; smoking cessation; doxazosin; medication effect on smoking lapse behavior; medication effect on smoking cessation; stress

Summary:

      The purpose of this study is to examine whether doxazosin will attenuate the ability of
      stress to precipitate smoking lapse behavior in treatment seeking daily smokers. Participants
      will participate in a smoking cessation attempt after the laboratory sessions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 18-60

          -  Able to read and write English

          -  Smoker

          -  Motivated to Quit Smoking

        Exclusion Criteria:

          -  Any significant current medical conditions that would contraindicate smoking

          -  Current Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) abuse or
             dependence of other substances, other than nicotine dependence or alcohol abuse

          -  Positive test results at intake appointment on urine drug screens for illicit drugs

          -  Past 30 day use of psychoactive drugs including anxiolytics and antidepressants

          -  Women who are pregnant or nursing

          -  Suicidal, homicidal or evidence of current severe mental illness such as
             schizophrenia, bipolar disorder or major depression, or anxiety disorders

          -  Participants who have donated blood within the past 6 weeks

          -  Individuals who are currently taking other medications prescribed for smoking
             cessation

          -  Specific exclusions for administration of doxazosin or any alpha blocker
Study Of Letrozole With Or Without Palbociclib (PD-0332991) For The First-Line Treatment Of Hormone-Receptor Positive Advanced Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: PD 0332991; letrozole; letrozole
Intervention description: 125 mg/d capsules orally for 3 out of 4 weeks in repeated cycles; 2.5 mg/d tablets orally on a continuous regimen; 2.5 mg/d tablets orally on a continuous regimen
Intervention MeSH terms: Letrozole; Palbociclib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)
Enrollment: 177.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hormone-receptor positive advanced breast cancer

Summary:

      The study is aimed to confirm that letrozole + PD 0332991 is safe and tolerable and to assess
      the effect of the combination on advanced breast cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inoperable estrogen receptor positive and HER2 negative breast cancer.

          -  Postmenopausal status.

          -  Tumor tissue (archived acceptable) available for biomarker studies. For Phase 2 Part 2
             - CCND1 amplification and/or loss of p16 as determined by the central laboratory.

          -  Acceptable bone marrow, liver and kidney function.

        Exclusion Criteria:

          -  Prior or concomitant treatment for advanced breast cancer.

          -  Other major cancer in the past 3 years.

          -  Important cardiovascular events in the past 6 months.
N-acetylcysteine in the Treatment of PTSD and Addiction
Condition: PTSD; Addiction
MeSH terms: Behavior, Addictive
Intervention: N-acetylcysteine; Placebo
Intervention description: NAC pills were administered each week. NAC is a N acetyl pro-drug of the naturally-occurring amino acid cystine. NAC is a white, crystalline powder with the molecular formula C5H9NO3S and with a molecular weight of 163.2.; Identical looking placebo pills were administered each week.
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Examine the effects of N-acetylcysteine on PTSD symptoms, craving and substance use in
      veterans with PTSD and comorbid substance use disorders.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-65 year old

          -  U.S. military Veteran, Reservist, or National Guard member

          -  DSM-IV diagnostic criteria for current (past 6 months) SUD and PTSD or subthreshold
             PTSD (i.e., met criteria for cluster B (re-experiencing) and either cluster C
             (avoidance) or D (hyperarousal), as well as duration of one month and clinically
             significant impairment)

          -  Score of > 21 on the Mini-Mental State Exam (MMSE).

        Exclusion Criteria:

          -  Unstable medical conditions

          -  Bipolar or psychotic disorders

          -  Seizures or asthma

          -  Prior treatment with NAC

          -  Suicidality

          -  Enrolled in ongoing PTSD treatment (pharmacotherapy or psychosocial)

          -  Females: could not be pregnant or lactating
CC-5013 (Lenalidomide) and Rituximab in Waldenstrom's Macroglobulinemia
Condition: Waldenstrom's Macroglobulinemia
MeSH terms: Waldenstrom Macroglobulinemia
Intervention: CC-5103 (lenalidomide); Rituximab
Intervention description: Taken orally once a day for 21 days followed by 7 days of no CC-5103 (lenalidomide); Begins on week 2 of treatment and is given intravenously once a week for 4 weeks
Intervention MeSH terms: Rituximab; Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: CC-5103 (lenalidomide); rituximab; Waldenstrom's macroglobulinemia

Summary:

      The purpose of this study is to determine the number of patients with Waldenstrom's
      macroglobulinemia that will benefit from treatment with CC-5103 (lenalidomide) and rituximab,
      what the side effects are and how long the benefit will last.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinicopathological diagnosis of Waldenstrom's macroglobulinemia using consensus panel
             criteria

          -  Age 18 years or older

          -  CD20 positive based on any previous bone marrow immunohistochemistry or flow
             cytometric analysis

          -  All previous cancer therapy, including radiation, hormonal therapy and surgery, must
             have been discontinued at least 4 weeks prior to treatment in this study

          -  Measurable disease, defined as presence of immunoglobulin M paraprotein with a minimum
             IgM level of equal to or greater than 2 times the upper limit of normal.

          -  ECOG performance status of 0-2

          -  Absolute neutrophil count ≥ 100,000,000/L

          -  Platelet count ≥ 50,000,000,000/L

          -  Hemoglobin > 8 g/dL

          -  Serum creatinine < 2.5 mg/dL

          -  Total bilirubin < 1.5 mg/dL

          -  AST and ALT < 2.5 x ULN

          -  Disease free of prior malignancies fir 5 years with exception of currently treated
             basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or
             breast

        Exclusion Criteria:

          -  Any serious medical condition, laboratory abnormality, or psychiatric illness

          -  Pregnant or lactating women

          -  Prior therapy with rituximab or CC-5103

          -  Known hypersensitivity to thalidomide

          -  Development of erythema nodosum if characterized by a desquamating rash while taking
             thalidomide or similar drugs.

          -  Concurrent use of other anti-cancer agents or treatments
Pilot Indocyanine Green Imaging for Mapping of Arm Draining Lymphatics & Nodes in Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: SPY Elite Imaging; Indocyanine Green; Isosulfan blue; 99technetium-sulfur colloid radiolabel
Intervention description: A camera that is directed into the axillary cavity to try to capture an image of the tumor site labeled with Indocyanine green before and after excising sentinel nodes; started at 1mg /mL
If fluorescence is not detected with this dose, then it will be increased by 50%.; 3 to 5 mL
If fluorescence is not detected with this dose, then it will be increased by 50%.
Intervention MeSH terms: Technetium Tc 99m Sulfur Colloid
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: Female
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if Indocyanine Green (IC-GREEN) is comparable to
      isosulfan blue (IS-BLUE) in the identification of arm lymphatics and arm-draining nodes
      during nodal staging procedures in breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to understand and the willingness to sign a written informed consent document.

          -  Signed written informed consent.

          -  Women undergoing sentinel lymph node biopsy.

          -  Women with breast cancer with known or suspected lymph node involvement.

          -  Women undergoing sentinel node identification and completion axillary lymph node
             dissection.

          -  Women of 18 years of age or older.

          -  Eastern Cooperative Oncology Group (ECOG) or Karnofsky Performance Status 0,1,2.

          -  Complete Blood Count (CBC) and basic Metabolic Panel within 6 months

        Exclusion Criteria:

          -  History of liver or kidney failure will not be eligible.

          -  Allergies to iodine containing products will not be eligible.

          -  Women who are pregnant will not be eligible.

          -  Psychiatric or addictive disorders or other conditions that, in the opinion of the
             investigator, would preclude the patient from meeting the study requirements.
Safety and Efficacy of Vaniprevir (MK-7009) With Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) in Treatment-Experienced Hepatitis C Virus (HCV) Participants (MK-7009-009)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Vaniprevir; Pegylated Interferon (Peg-IFN); Ribavirin (RBV); Placebo (PBO)
Intervention description: Participants took capsules containing 100 mg Vaniprevir twice daily (b.i.d.), three in the morning (300 mg and 600 mg regimens) and three in the evening (600 mg regimen only), orally, for 24 or 48 weeks.; Participants used prefilled syringe containing 180 µg/0.5 mL Peg-IFN, for weekly subcutaneous injection, for 24 or 48 weeks; Participants took tablets containing 200 mg RBV, 5 or 6 tablet dosage based on the participant's weight, with food, for 24 or 48 weeks. The dose was 1000 mg for participants weighing <=75 kg and 1200 mg for participants weighing >75 kg.; Participants took PBO capsules matching Vaniprevir capsules, three in the morning and three in the evening, for 24 or 48 weeks.
Intervention MeSH terms: Interferons; Ribavirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 285.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: hepatitis C

Summary:

      The purpose of this study is to test the safety, tolerability, and efficacy of 4 regimens of
      Vaniprevir + Peg-IFN and Ribavirin as compared to Placebo (PBO) + Peg-IFN/RBV. The primary
      hypotheses are that Vaniprevir is well tolerated, and that Vaniprevir 600 mg twice daily
      (b.i.d.) is superior to the control regimen for the percentage of non-cirrhotic (NC)
      participants achieving undetectable HCV ribonucleic acid (RNA) 24 weeks after the end of
      study therapy (SVR24).
    

Eligibility criteria:

        Inclusion criteria:

          -  Has chronic HCV genotype 1 infection

          -  Is treatment-experienced

          -  For the non-cirrhotic population, has had a liver biopsy without evidence of cirrhosis
             and hepatocellular carcinoma; for the cirrhotic population, has had a liver biopsy
             with evidence of cirrhosis and without evidence of hepatocellular carcinoma.

        Exclusion criteria:

          -  Has not tolerated previous course peg-IFN and RBV

          -  Is unlikely to tolerate at least 24 weeks of continuous therapy with Peg-IFN and RBV

          -  Is co-infected with Human Immunodeficiency Virus (HIV) and/or hepatitis B

          -  Consumes excessive amounts of alcohol

          -  Has a history of drug or alcohol abuse

          -  If female, participant is pregnant or breastfeeding

          -  Has been in a clinical trail with an investigational drug in the last 30 days

          -  Has used IFN/Peg-IFN and RBV in the last 3 months
Marinol in Trichotillomania or Obsessive Compulsive Disorder
Condition: Trichotillomania; Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder; Trichotillomania
Intervention: Dronabinol
Intervention description: 2.5mg-15mg by mouth once a day for twelve-weeks
Intervention MeSH terms: Dronabinol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Skin Picking; OCD; Trichotillomania; Pathological Skin Picking

Summary:

      The goal of the proposed study is to evaluate the efficacy and safety of dronabinol in
      individuals with obsessive-compulsive disorder (OCD) or the obsessive-compulsive spectrum
      disorders, trichotillomania (TTM) or pathological skin picking (PSP). Fifteen patients with
      OCD, TTM, or PSP will receive 12 weeks of open-label treatment with dronabinol. The
      hypothesis to be tested is that dronabinol will be effective and well tolerated in patients
      with these disorders. The proposed study will provide needed data on the treatment of a
      disabling disorder that currently lacks a clearly effective treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18-65 years

          2. Obsessive-compulsive disorder (OCD), Trichotillomania (TTM), or Pathological Skin
             Picking (PSP) as the primary psychiatric diagnosis

          3. (If OCD) - Subject reports ≥two failed treatments using selective serotonin reuptake
             inhibitors (SSRIs) for their OCD

          4. Women's participation required negative results on a beta-human chorionic gonadotropin
             pregnancy test and stable use of a medically accepted form of contraception.

          5. Signed informed consent before entry into the study.

        Exclusion Criteria:

          1. Unstable medical illness or clinically significant abnormalities on laboratory tests
             or physical examination at screening visit

          2. Current pregnancy or lactation, or inadequate contraception in women of childbearing
             potential

          3. A need for medication other than dronabinol with possible psychotropic effects

          4. History of hypersensitivity to any cannabinoid or sesame oil

          5. Lifetime history of bipolar disorder type I or II, dementia, or schizophrenia as
             determined by the Structured Clinical Interview for DSM-IV

          6. Current (past 12-months) DSM-IV substance abuse or dependence

          7. Positive urine drug screen at screening

          8. Initiation of cognitive behavior therapy within 3 months prior to study baseline

          9. Baseline score of ≥ 17 on the Hamilton Depression Rating Scale (17-item HDRS

         10. Suicidality based on clinical interview

         11. History of head injury or neurological disorder (such as seizures)
A Vehicle Controlled Study to Evaluate Safety and Efficacy of Topical TMB-001 for Treatment of Congenital Ichthyosis
Condition: Congenital Ichthyosis
MeSH terms: Ichthyosis; Ichthyosis, Lamellar; Ichthyosiform Erythroderma, Congenital
Intervention: Isotretinoin; Vehicle
Intervention description: Topical Isotretinoin ointment; Topical Vehicle Ointment
Intervention MeSH terms: Isotretinoin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Randomized, Parallel, Double-Blind, Vehicle-Controlled Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blind
Enrollment: 34.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate the efficacy and safety of two concentrations of
      topically applied ointment formulation of isotretinoin called TMB-001 (0.05% and 0.1%
      isotretinoin) in subjects 9 years of age and older for the treatment of congenital ichthyosis
      (CI), including recessive X-linked ichthyosis (RXLI) and autosomal recessive congenital
      ichthyosis-lamellar ichthyosis (ARCI-LI) subtypes.

      Funding Source FDA-OOPD
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is male or female, 9 years of age or older at Visit 2 (Baseline)

          -  Subject has provided written informed consent

          -  Females of child bearing potential must be surgically sterile or agree to 2 forms of
             birth control

          -  Subject has clinical diagnosis of Congenital Ichthyosis with genetic confirmation of
             subtype

          -  Subject has between 10% and 90% total BSA affected by Congenital Ichthyosis

          -  Subject has at least 2 VIIS assessment areas with a scaling score of 3 or greater

        Exclusion Criteria:

          -  Subject has inflammatory skin diseases unrelated to ichthyosis

          -  Subject has used other prohibited topical treatments in the assessment areas within
             certain days from baseline

          -  Subject has used systemic retinoids within12 weeks of baseline

          -  Subject has untreated secondary infections

          -  Subject has lesions suspicious for skin cancer or untreated skin cancers
Study Assessing Efficacy and Safety of AKST4290 in Subjects With Parkinson's Disease on Stable Dopaminergic Treatment
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: AKST4290; Placebo
Intervention description: Oral AKST4290; Oral Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 110.0
Sex: All
Minimum age: 50 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Parkinson's Disease; Dementia; Movement Disorder; Shaking Palsy

Summary:

      This study will evaluate the efficacy and safety of AKST4290 in subjects with Parkinson's
      Disease who are currently on stable dopaminergic treatment.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Diagnosis of clinically established or clinically probable PD according to MDS-PD
             criteria with at least 1 year of PD symptoms.

          -  Modified Hoehn and Yahr ≤2.5.

          -  Have notable motor worsening during off-medication state.

          -  Clear-cut improvement of motor response to levodopa medications, as assessed by the
             investigator.

          -  Must be on stable dopaminergic therapy (e.g., levodopa, dopamine agonists, monoamine
             oxidase inhibitors, catechol-O-methyl transferase inhibitors, amantadine), for at
             least 8 weeks prior to enrollment and remain on stable dose during the 12-week
             treatment period.

          -  Female subjects must not be pregnant or breastfeeding. Women of childbearing potential
             (WOCBP) must have a negative pregnancy test at Screening. WOCBP must agree to use
             highly effective contraception prior to study entry. Male subjects must be willing to
             use a barrier method of contraception.

        Key Exclusion Criteria:

          -  Secondary or atypical parkinsonian syndromes, for example, patients with parkinsonism
             from encephalitis, metabolic disorders, vascular parkinsonism, drug-induced
             parkinsonism, multiple system atrophy, corticobasal ganglia degeneration, progressive
             supranuclear palsy, Lewy body dementia.

          -  History of any brain surgery for PD (e.g., pallidotomy, deep brain stimulation, or
             fetal tissue transplant).

          -  Conditions affecting the peripheral or central nervous system, unless related to PD,
             that would affect the ability to adequately perform the MDS-UPDRS and motor
             assessments: i.e., severe sensory neuropathy affecting arm or leg function, or stroke
             affecting motor or gait function.

          -  Significant alcohol or drug abuse within past 2 years.

          -  Based on ECG reading, subjects with a risk of QT prolongation.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.