bioihbjkbjnl/mcl2 huggingface dataset:
Cannabidiol Use to Reduce Cravings in Individuals With Opioid Use Disorder on Buprenorphine
Condition: Opioid-use Disorder
MeSH terms: Opioid-Related Disorders; Substance-Related Disorders
Intervention: Cannabidiol 600mg
Intervention description: All subjects will receive 600mg of oral cannabidiol for 3 days in an open-label fashion. Cannabidiol will be provided using Epidiolex™ oral solution 100mg/mL, and the drug will be procured by the Brigham and Women's Hospital (BWH) Investigational Drug Services (IDS) pharmacy. The first dose will be administered at the BWH Center for Clinical Investigation, while doses 2 and 3 will be self-administrated at home. The CBD will be repacked in pre-drawn syringes for the subjects to self-administer at home.
Intervention MeSH terms: Cannabidiol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this week-long study is to determine the impact of cannabidiol on cue-induced
      cravings among individuals with opioid use disorder who are stable on sublingual
      buprenorphine treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) opioid use
             disorder, severe

          -  Currently in treatment with methadone or buprenorphine

        Exclusion Criteria:

          -  Requiring level of care higher than outpatient treatment for alcohol,
             sedative/hypnotics, or stimulants

          -  Any current mood episode requiring level of care higher than outpatient treatment

          -  History of psychotic disorder or bipolar disorder

          -  Currently pregnant

          -  Hepatic liver enzymes greater than 3x upper normal limit

          -  Hypersensitivity to cannabinoids or sesame oil (cannabidiol solution comes in sesame
             oil emulsion)

          -  Currently taking any medications with known significant pharmacokinetic interactions
             with CBD
Safety, Tolerability and Efficacy of AVP-786 for the Treatment of Disinhibition
Condition: Disinhibition Syndrome
Intervention: AVP-786; Placebo
Intervention description: d6-DM/Q; matching placebo
Intervention MeSH terms: Quinidine; Dextromethorphan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1.0
Sex: All
Minimum age: 50 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Disinhibition

Summary:

      Treatment of disinhibition syndrome in participants with Neurodegenerative Disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented diagnosis of a Neurodegenerative Disorder including frontotemporal
             dementia, Alzheimer's disease (AD), progressive supranuclear palsy (PSP), corticobasal
             degeneration (CBD), dementia with Lewy bodies (DBL), vascular cognitive disorders, or
             Huntington's disease, at least 3 months prior to Baseline

          -  The participant has behavior from 2 of the 3 categories of disinhibited behavior from
             the definition of the behavioral variant of frontotemporal dementia

          -  The behavioral changes are not due to a pre-existing major psychiatric disorder (e.g.,
             schizophrenia, bipolar disease, etc.) and are not due to the direct effect of systemic
             illness, drug action, or substance use

          -  Disinhibition scale score of ≥4 on the 3 core disinhibition items of the Frontal
             Behavioral Inventory (FBI) at Screening and Baseline

        Exclusion Criteria:

          -  Participants with symptoms of disinhibition that is not secondary to Neurodegenerative
             Disorders

          -  Participants with myasthenia gravis

          -  Participants with co-existent clinically significant or unstable systemic diseases
             that could confound the interpretation of the safety results of the study (e.g.,
             malignancy [except skin basal-cell carcinoma or untreated prostate cancer], poorly
             controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or
             hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or
             unstable valvular heart disease)
Safety & Efficacy of BCT197A2201 in COPD Patients Presenting With an Exacerbation
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: BCT197; Prednisone placebo; BCT197 placebo; Prednisone
Intervention description: capsules; capsules; capsules
Intervention MeSH terms: Prednisone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 183.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease; Exacerbation; Pulmonary Inflammation

Summary:

      This study will assess preliminary parameters of safety and efficacy of a single dose of
      BCT197 in patients with a Chronic Obstructive Pulmonary Disease (COPD) exacerbation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with COPD (Stage II to IV) with a COPD exacerbation.

          -  Smoking history of 10 pack years.

          -  Females must not be of child-bearing potential.

        Exclusion Criteria:

          -  Use of steroids in the last 30 days or calcium channel blockers in the last 48 hours.

        Other protocol-defined inclusion/exclusion criteria may apply
Evaluation of LUM001 in the Reduction of Pruritus in Alagille Syndrome
Condition: Alagille Syndrome
MeSH terms: Alagille Syndrome; Pruritus; Syndrome
Intervention: LUM001; Placebo
Intervention description: LUM001 administered orally; Placebo administered orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 37.0
Sex: All
Minimum age: 12 Months
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      The study is a randomized, double-blind, placebo-controlled study in children with Alagille
      Syndrome (ALGS). The study will investigate the effects of LUM001, compared to placebo, on
      pruritus, serum bile acids, liver enzymes, and other biochemical markers in patients with
      ALGS.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of Alagille Syndrome

          2. Evidence of cholestasis

          3. Moderate to severe pruritus

          4. Ability to understand and willingness to sign informed consent/assent prior to
             initiation of any study procedures

        Exclusion Criteria:

          1. Surgical disruption of the enterohepatic circulation

          2. Liver transplant

          3. History or presence of other concomitant liver disease

          4. Females who are pregnant or lactating

          5. Known HIV infection
LGX818 for Patients With BRAFV600 Mutated Tumors
Condition: Solid Tumor; Hematologic Malignancies
MeSH terms: Hematologic Neoplasms
Intervention: LGX818
Intervention description: LGX818 will be dosed on a flat scale of 300 mg (e.g., 3 x 100 mg capsules) once daily on a continuous dosing cycle. A complete treatment cycle is defined as 28 days. There will be no breaks between dosing cycles.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this signal seeking study is to determine whether treatment with LGX818
      demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic
      malignancies to warrant further study
    

Eligibility criteria:

        Inclusion Criteria

          -  Patient has a confirmed diagnosis of a select solid tumor (except with a primary
             diagnosis of melanoma and colorectal cancer (CRC)) or hematologic malignancies and is
             in need of treatment because of progression or relapse.

          -  Patient's tumor has been evaluated and pre-identified as having a tumor with a
             BRAFV600 mutation at a CLIA certified laboratory.

          -  Patient must have received at least one prior treatment for recurrent, metastatic and
             /or locally advanced disease and for whom no standard therapy options are anticipated
             to result in a durable remission.

          -  Patient must have progressive and measurable disease per RECIST 1.1. or other
             appropriate hematological response criteria.

          -  Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

        Exclusion Criteria:

          -  Patient has received prior treatment with LGX818.

          -  Patients with Central Nerve System (CNS) metastasis or leptomeningeal carcinomatosis.

          -  Patient has received chemotherapy or other anticancer therapy ≤ 4 weeks (6 weeks for
             nitrosourea, antibodies or mitomycin-C) prior to starting study drug.

          -  Patients with acute or chronic pancreatitis.

          -  Patients with impaired cardiac function or clinically significant cardiac diseases.

          -  Patients with another primary malignancy within 3 years prior to starting study
             treatment, with the exception of adequately treated basal cell carcinoma, squamous
             cell carcinoma or other non-melanomatous skin cancer, or in-situ carcinoma of the
             uterine cervix.
Comparison of Intravenous Cefazolin Plus Oral Probenecid With Oral Cephalexin for the Treatment of Cellulitis
Condition: Cellulitis
MeSH terms: Cellulitis
Intervention: IV cefazolin plus oral probenecid and placebo cephalexin; Oral cephalexin and saline IV plus probenecid placebo
Intervention description: Intravenous cefazolin 2 g IV plus probenecid 1 g daily plus cephalexin placebo orally four times daily.; Cephalexin 500 mg orally four times daily plus saline IV and oral probenecid placebo daily
Intervention MeSH terms: Cefazolin; Cephalexin; Probenecid
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: 19 Years
Healthy volunteers: No
Keywords: Cellulitis; Emergency Department; Cefazolin; Probenecid; Cephalexin

Summary:

      The purpose of this study is to determine whether oral cephalexin is equivalent to
      intravenous cefazolin plus oral probenecid for the treatment of uncomplicated skin and soft
      tissue infections in patients that present to the emergency department.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients presenting to the emergency department with a presumed diagnosis of mild to
             moderate skin and soft tissue infection

          -  Deemed well enough to be treated as an outpatient

          -  19 years of age or older

        Exclusion Criteria:

          -  known allergy to study drugs

          -  known chronic kidney disease with a creatinine clearance <30 mL/min

          -  known previous methicillin-resistant staphylococcus aureus (MRSA) infection

          -  use of antibiotics for greater than 24 hours in the past 7 days

          -  wound/abscess requiring operative debridement or incision and drainage

          -  suspected necrotizing fasciitis, osteomyelitis or septic arthritis

          -  febrile neutropenia

          -  concomitant documented bacteremia

          -  Two or more signs of systemic sepsis

          -  new altered mental status

          -  infections at a site involving prosthetic materials

          -  animal or human bite wound infections

          -  post-operative wound infections

          -  known peripheral vascular disease

          -  superficial thrombophlebitis

          -  pregnant/breastfeeding

          -  obesity (BMI > 30 kg/m2)
Open Label Extension Study To Investigate Long Term Safety, Tolerability And Efficacy Of Pf-02545920 In Subjects With Huntington's Disease Who Completed Study A8241021
Condition: Huntington's Disease
MeSH terms: Huntington Disease
Intervention: 20 mg BID of PF-02545920
Intervention description: All subject who completed A8241021 will receive 20 mg BID (with or without titration)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 188.0
Sex: All
Minimum age: 30 Years
Maximum age: 66 Years
Healthy volunteers: No
Keywords: Huntington; chorea; total motor score; CAG repeat: total functional capacity; motor cognitive and behavioral symptoms

Summary:

      This study is a 12 month open label extension study of PF-02545920 20 mg dosed BID following
      study A8241021 in subjects with HD. Primary endpoints will be to assess long-term safety and
      tolerability of 20 mg BID of PF-02545920. Secondary endpoints will be the change from
      baseline in the Total Motor Score (TMS)assessment, and/ior the Total maximum Chorea (TMC)
      assessment of the Unified Huntington Disease Rating Scale (UHDRS) after 6 and 12 months of
      treatment, and Clinical Global Impression-Improvement score after 6 and 12 months of
      treatment. Subjects, who were assigned to the 20 mg PF-02545920 dose group in the preceding
      A8241021 study, will receive 20 mg PF-02545920 without any titration. All other subjects will
      be titrated to the 20 mg BID dose as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15
      mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Up to 260
      subjects may take part in this open label extension
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have completed study A8241021

          -  Diagnosis of HD, including ≥36 CAG repeats.

        Exclusion Criteria:

          -  Significant neurological disorder other than Huntington's disease.

          -  WBC ≤ 3500/mm3 AND/OR ANC ≤ 2000/mm3 and history of neutropenia or
             myeolo-proliferative disorders.

          -  Any drug related SAE experienced during study A8241021 which were not approved as
             acceptable for enrollment in A8241022.
Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: DSXS
Intervention description: twice daily for 28 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No

Summary:

      An open label, safety study to assess the potential for adrenal suppression following maximal
      use treatment with DSXS administered twice daily for 28 days in patients with moderate to
      severe plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with a confirmed diagnosis of plaque psoriasis, patients 2-17 years of age
             with ≥ 10% BSA affected and patients age 18 years of age or older with ≥ 20% BSA
             affected

          2. Investigator Global Assessment (IGA) score of 3 (moderate) or 4 (severe) at baseline
             for the overall disease severity.

          3. Results from a cortisol response test that are considered normal and show no evidence
             of any abnormal HPA function or adrenal response

        Exclusion Criteria:

          1. Patients under 2 years of age.

          2. Investigator Global Assessment (IGA) of less than 3 (moderate) or greater than 4
             (severe) at baseline.

          3. Current diagnosis of types of psoriasis other than stable plaque psoriasis (i.e.,
             erythrodermic, exfoliative or pustular psoriasis).

          4. Results from a cortisol response test that show evidence of any abnormal HPA function
             or adrenal response
PROCLAIM: CX-072-002: Study of PD-L1 Probody Therapeutic CX-072 in Combination With Other Anticancer Therapy in Adults With Solid Tumors
Condition: Solid Tumor; Unresectable or Metastatic Melanoma
MeSH terms: Neoplasms; Melanoma
Intervention: CX-072; Ipilimumab
Intervention description: CX-072 in combination with ipilimumab; CX-072 in combination with ipilimumab
Intervention MeSH terms: Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Combination; ipilimumab; Cancer; checkpoint inhibitor; PD-L1; CTLA-4; PROCLAIM; PROCLAIM-CX-072; Relapsed; Refractory

Summary:

      To obtain evidence of antitumor effect of CX-072 in combination with anticancer therapy in
      adult patients with solid tumor based upon overall response rate by Response Evaluation
      Criteria in Solid Tumors (RECIST)
    

Eligibility criteria:

        Inclusion Criteria:

          1. At least 18 years of age

          2. Measurable disease as defined by RECIST v1.1

          3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1

          4. Agree to provide tumor tissue and blood samples for biomarker assessment

        Exclusion Criteria:

          1. Treatment with cytotoxic chemotherapy, biologic agents, radiation, immunotherapy, or
             any investigational agent within 28 days prior to the first dose of study treatment.

          2. Prior therapy with a chimeric antigen receptor T cell-containing regimen

          3. History of active autoimmune disease(s) including but not limited to inflammatory
             bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis,
             systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, autoimmune
             neuropathies, type 1 insulin-dependent diabetes mellitus

          4. History of myocarditis regardless of the cause

          5. History of intolerance to prior checkpoint inhibitor therapy defined as the need to
             discontinue treatment due to an irAE

          6. History of any syndrome or medical condition that required treatment with systemic
             steroids (≥10 mg daily prednisone equivalents) or immunosuppressive medications.

          7. History of severe allergic or anaphylactic reactions to human mAb therapy or known
             hypersensitivity to any Probody therapeutic
Milk Thistle in Trichotillomania in Children and Adults
Condition: Trichotillomania; Hair Pulling Disorder
MeSH terms: Trichotillomania
Intervention: Milk Thistle; Placebo
Intervention MeSH terms: Silymarin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 10 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The goal of the proposed study is to evaluate the efficacy and safety of silymarin (milk
      thistle) in children and adults with trichotillomania. The hypothesis to be tested is that
      silymarin will be more effective and well tolerated in children and adults with
      trichotillomania compared to placebo. 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. Males and females ages 10-65.

          2. Diagnosis of current trichotillomania (TTM) based on DSM-5 criteria and confirmed
             using the clinician-administered Structured Clinical Interview for DSM-5 (SCID);

          3. Hair-pulling behavior within 2 weeks prior to enrollment;

          4. Child able and willing to provide active assent for participation;

          5. Legal guardian available to provide consent for participation.

        Exclusion Criteria:

          1. Infrequent hair-pulling (i.e. less than one time per week) that does not meet DSM-5
             criteria for trichotillomania;

          2. Unstable medical illness as determined by the investigator;

          3. History of seizures;

          4. Current use of stimulants coinciding with onset or exacerbation of trichotillomania
             symptoms or other current medications coinciding with exacerbation or onset or
             trichotillomania symptoms;

          5. Clinically significant suicidality (defined by the Columbia Suicide Severity Rating
             Scale);

          6. Baseline score of ≥17 on the Hamilton Depression Rating Scale (17-item HDRS);

          7. Lifetime history of bipolar disorder type I or II, schizophrenia, autism, any
             psychotic disorder, or any substance use disorder;

          8. Initiation of psychotherapy or behavior therapy within 3 months prior to study
             baseline;

          9. Previous treatment with milk thistle;

         10. Any history of psychiatric hospitalization in the past year.
OTO-201 for the Treatment of Otitis Externa
Condition: Otitis Externa
MeSH terms: Otitis; Otitis Externa
Intervention: OTO-201 (ciprofloxacin)
Intervention MeSH terms: Ciprofloxacin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 6 Months
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Otitis externa; Swimmer's ear; Ear infection

Summary:

      This is a 1-month, multicenter, open-label study in subjects with unilateral otitis externa.
      Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear. The study
      is designed to characterize safety, procedural factors and clinical effect of OTO-201
      administered in subjects with otitis externa.
    

Eligibility criteria:

        Inclusion Criteria includes, but is not limited to:

          -  Subject is a male or female aged 6 months to 80 years, inclusive

          -  Subject has a clinical diagnosis of unilateral otitis externa

          -  Subject or subject's caregiver is willing to comply with the protocol and attend all
             study visits

        Exclusion Criteria includes, but is not limited to:

          -  Subject has tympanic membrane perforation

          -  Subject has a history of known immunodeficiency disease

          -  Subject has fungal otitis externa, based on clinical signs