bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 2a Study to Assess Safety, Daily Symptoms, PK, and Biomarkers of YPL-001 in COPD Patients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: YPL-001 80 mg; YPL-001 160 mg; Placebo
Intervention description: twice daily [BID]; twice daily [BID]; twice daily [BID]
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 61.0
Sex: All
Minimum age: 30 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      This is a Phase 2a, proof-of-concept, multicenter, randomized, double-blind, double dummy,
      3-treatment, parallel study, with low and high YPL 001 doses (low dose and high dose twice
      daily [BID]) and a placebo control in moderate to severe Chronic Obstructive Pulmonary
      Disease (COPD) patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult males and/or females, 30 to 85 years of age (inclusive).

          -  History of COPD for at least 12 months prior to screening.

          -  Diagnosed with COPD as defined by the American Thoracic Society (ATS)/European
             Respiratory Society (ERS) guidelines with symptoms compatible with COPD for at least
             12 months prior to screening.

          -  Classified as moderate to severe COPD based on the current severity classification
             GOLD Stage 2-3 disease in terms of post-bronchodilator spirometry at screening

          -  etc.

        Exclusion Criteria:

          -  History of life-threatening COPD including respiratory arrest, intensive care unit
             admission and/or requiring intubation.

          -  History of more than 2 hospitalizations for COPD within 12 months prior to screening.

          -  Presentation of an acute exacerbation of COPD that will be associated with increase
             sputum volume or change in sputum color within 4 weeks before Day 1 of the Run-in
             Period.

          -  Evidence of pulmonary heart disease, or clinically significant pulmonary hypertension.

          -  etc.
This Study Tests How BI 655130 Works in Patients With Active Ulcerative Colitis. The Study Also Tests How Well BI 655130 is Tolerated and Whether it Helps the Patients
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Spesolimab
Intervention description: 12 weeks treatment
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 primary objective of this trial is to understand the mechanism of action of BI655130 in
      patients with UC

      Secondary objectives are to explore clinical effect, safety and tolerability (including
      immunogenicity) of BI 655130 treatment
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 - 75 years at screening

          -  Diagnosis of UC >= 3 months prior to screening.

          -  Moderately to severely active UC as confirmed by Mayo Score ≥6

          -  Receiving conventional, non-biologic therapy for UC.

          -  Negative colon cancer screening

          -  Further inclusion criteria apply

        Exclusion Criteria:

          -  Prior use of any biological treatment in the past (e.g.integrin inhibitors, IL12/23 or
             IL23 inhibitors, any investigational biological drugs)

          -  Extensive colonic resection

          -  Evidence of infection with C. difficile or other intestinal pathogen < 30 days prior
             to screening

          -  Active or latent tuberculosis

          -  Further exclusion criteria apply
An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Subjects With Alagille Syndrome (ALGS)
Condition: Alagille Syndrome
MeSH terms: Liver Diseases; Alagille Syndrome; Syndrome
Intervention: LUM001 (Maralixibat)
Intervention description: Dosing of LUM001 also known as Maralixibat (MRX) with the objective of achieving optimal control of pruritus at a dose level that is tolerated by the participant and up to a maximum daily dose of 560 micrograms per kilogram (mcg/kg).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 12 Months
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this extension study is to determine the long-term safety and tolerability of
      an investigational treatment (LUM001 also known as Maralixibat) in children with ALGS who
      have completed participation in a core LUM001 treatment protocol. Efficacy will be assessed
      by evaluating the effect of LUM001 on pruritus, biochemical markers of pruritus, as well as
      biochemical markers of cholestasis and liver disease.
    

Eligibility criteria:

        Participation for an individual patient is expected to be approximately 72 weeks.

        Patients who complete 72 weeks of treatment may be eligible to receive treatment for up to
        52 weeks during the follow-up treatment period and patients who completed the 124 weeks of
        treatment may be eligible to enter the additional long-term follow-up period.
Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: ASN002
Intervention description: Daily dose of ASN002 for up to 110 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 162.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: eczema

Summary:

      This is a randomized open label study to evaluate the long term safety of ASN002 in subjects
      with moderate to severe atopic dermatitis (AD).
    

Eligibility criteria:

        Inclusion Criteria

          -  Subject with a history of moderate to severe atopic dermatitis who participated in the
             preceding ASN002AD-201 and ASN002AD-101 study

          -  Subject must be a candidate for prolonged open label ASN002/gusacitinib treatment
             according to the investigator's judgment.

          -  Subject has been using an emollient daily for at least 1 week prior to Day 1 and
             agrees to continue using that same emollient daily throughout the study.

          -  Men and women participating in the study must use medically acceptable birth control
             or total abstinence from sexual intercourse

          -  Subject is willing to participate and is capable of giving informed consent. Note:
             Consent must be obtained prior to any study-related procedures.

          -  Subjects must be willing to comply with all study procedures and must be available for
             the duration of the study.

          -  Subject has a body mass index (BMI) ≤ 38 kg/m2.

        Exclusion Criteria

          -  Subject is a female who is breastfeeding, pregnant, or who is planning to become
             pregnant during the study.

          -  Subject has clinically infected atopic dermatitis.

          -  A serious uncontrolled condition including hypertension, history of tuberculosis,
             hepatitis B or C infection, immune deficiency, heart disease, heart conduction
             disorder, diverticulitis, diabetes, reflux disease requiring protocol pump inhibitor
             therapy, malabsorption syndrome, or cancer

          -  Subject has a history of skin disease or presence of skin condition that, in the
             opinion of the investigator, would interfere with the study assessments.

          -  Subject has a history of eczema herpeticum within 12 months, and/or a history of 2 or
             more episodes of eczema herpeticum in the past.

          -  Willing to comply with discontinuation of certain treatments for AD, as directed by
             the Investigator.
Pregabalin as Treatment for Alcohol Use Disorder
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Intervention: Pregabalin
Intervention description: pregabalin up to 600 mg/day
Intervention MeSH terms: Pregabalin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: open label pilot study
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: alcohol use disorder; alcohol abuse; treatment; lyrica

Summary:

      The proposed protocol is an 8 week open label outpatient pilot trial of the safety and
      efficacy of pregabalin (Lyrica) in the treatment of alcohol use disorder. The primary
      objective of the study is to determine the efficacy of pregabalin in promoting alcohol
      abstinence among individuals with an alcohol use disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets DSM-5 criteria for current alcohol use disorder

          -  Reports drinking a minimum of 5 standard drinks for men or 4 standard drinks for women
             at least 4 days per week over the past 28 days

          -  Between the ages of 18 and 65

          -  Able to provide informed consent and comply with study procedures

        Exclusion Criteria:

          -  Subjects with any current psychiatric disorder as defined by DSM-5, other than AUD,
             that in the investigator's judgment might require intervention over the course of the
             study.

          -  Subjects receiving psychotropic medication treatment

          -  Evidence of moderate-to-severe alcohol withdrawal (CIWA-Ar > 13)

          -  History of alcohol withdrawal seizures or alcohol withdrawal delirium

          -  History of allergic reaction to candidate medication (pregabalin)

          -  Pregnancy, lactation, or failure in females patients to use adequate contraceptive
             methods

          -  Unstable physical disorders which might make participation hazardous

          -  Subjects who have a current DSM-5 diagnosis of moderate or severe substance use
             disorder, with the exception of alcohol, nicotine and caffeine use disorders. A
             diagnosis of a mild substance use disorder will not be exclusionary, as long as the
             current primary substance use disorder is alcohol.

          -  Are legally mandated to participate in alcohol use disorder treatment program

          -  Cognitively impaired
Study Of 323U66 SR In Major Depressive Disorder
Condition: Depressive Disorder
MeSH terms: Depressive Disorder; Depression
Intervention: bupropion hydrochloride
Intervention description: Study drug
Intervention MeSH terms: Bupropion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 234.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: MDD

Summary:

      This study was designed to evaluate the efficacy and safety in major depressive disorder
      patients.
    

Eligibility criteria:

        Inclusion criteria:

          -  Met DSM-IV-TR criteria for major depressive disorder for their current episode for at
             least 8 weeks prior to screening visit.

          -  Must give a written informed consent. But if the patient is under 20, both the patient
             himself/herself and his/her proxy consenter must give written informed consent.

          -  Must have rating scores as outlined.

        Exclusion criteria:

          -  Current or past history of seizure disorder or brain injury.

          -  Current or past history of anorexia or bulimia nervosa.

          -  History of manic episode.

          -  Past or current DSM- IV-TR diagnosis of schizophrenia or other psychotic disorder.

          -  Diagnosis of substance abuse (alcohol or drug) by the DSM-IV-TR criteria.

          -  Pregnant, possibly pregnant or lactating.

          -  Must not be suicidal.

          -  Blood pressure of SBP>160mmHg, DBP>100mmHg.

          -  History or complication of cancer or malignant tumour.
A Study of Nivolumab in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL)
Condition: Lymphoma
MeSH terms: Lymphoma
Intervention: Nivolumab
Intervention MeSH terms: Nivolumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether Nivolumab is effective in the treatment of
      Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory
      Primary Testicular Lymphoma (PTL)
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Pathologically confirmed PCNSL or PTL who failed or did not respond to at least 1 line
             of systemic therapy

          -  Measurable disease requirements on scans:

        PCNSL subjects should have at least one measurable extranodal brain lesion; PTL subjects
        should have at least 1 measurable extranodal lesion or nodal lesion

          -  Have tumor tissue for PD-L1 expression testing

          -  Must have a Karnofsky performance status of 70-100

        Exclusion Criteria:

          -  a) Intraocular PCNSL without evidence of brain disease b) PCNSL patients who cannot
             undergo MRI assessments c) PCNSL patients with systemic disease

          -  Patients with certain diseases such as active autoimmune disease, type I diabetes,
             hypothyroidism that needs hormone replacement, active infection, psychiatric disorder

          -  Prior malignancy active within the previous 3 years except for locally curable cancers
             that have been apparently cured, such as basal or squamous cell skin cancer,
             superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast

          -  Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4
             antibody, or any other antibody or drug specifically targeting T-cell co-stimulation
             or checkpoint pathways

        PCNSL, and PTL subjects with brain or spinal cord lesion who have received doses of more
        than 2 mg/day of dexamethasone or equivalent within the 14 days period prior to the first
        dose of nivolumab are excluded

        Other protocol defined inclusion/exclusion criteria could apply
LUX-Breast 2; Afatinib in HER2 (Human Epidermal Growth Factor Receptor)-Treatment Failures
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: Vinorelbine 25 mg/m2 weekly; Afatinib 40mg once daily (OD); Paclitaxel 80 mg/m2 weekly
Intervention description: Patients to additionally receive vinorelbine at a dose of 25 mg/m2 weekly on disease progression on afatinib monotherapy; Patient to receive afatinib monotherapy at a dose of 40 mg/d until progression of their disease; Patients to additionally receive paclitaxel at a dose of 80 mg/m2 weekly on disease progression on afatinib monotherapy
Intervention MeSH terms: Paclitaxel; Vinorelbine; Afatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The general aim of this study is to investigate the efficacy and safety of afatinib (BIBW
      2992) alone and in combination with weekly paclitaxel or weekly vinorelbine (in patients who
      progress on afatinib monotherapy within this trial) as treatment in patients with
      HER2-overexpressing, metastatic breast cancer, who failed HER2-targeted treatment in the
      neoadjuvant or adjuvant setting
    

Eligibility criteria:

        Inclusion criteria:

          1. Female patients >=18 years with proven diagnosis of HER2-overexpressing,
             histologically confirmed breast cancer

          2. Stage IV metastatic disease

          3. At least one measurable lesion according to RECIST 1.1 (Response Evaluation Criteria
             for Solid Tumours version 1.1). Skin, bone and brain lesions are considered non-target
             lesions

          4. Must have failed or progressed on either trastuzumab or lapatinib or trastuzumab and
             lapatinib treatment in the neoadjuvant and/or adjuvant setting

        Exclusion criteria:

          1. Prior first line therapy for metastatic breast cancer

          2. Known pre-existing interstitial lung disease

          3. Active brain metastases

          4. History or presence of clinically relevant cardiovascular abnormalities such as
             uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable
             angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to
             trial treatment.

          5. Cardiac left ventricular function with resting ejection fraction of less than 50%.

          6. Prior treatment with Epidermal Growth Factor Receptor (EGFR)/HER2-targeted small
             molecules or antibodies other than trastuzumab and lapatinib in the neoadjuvant or
             adjuvant setting

          7. Prior treatment with paclitaxel in the past 12 months

          8. Must not have received prior vinorelbine treatment - Further exclusion criteria apply
Lorcaserin in the Treatment of Cocaine Use Disorder
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Intervention: Lorcaserin; Placebo Oral Capsule
Intervention description: Lorcaserin Capsule; sugar pill to mimic lorcaserin 10mg capsule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 272.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cocaine Use Disorder

Summary:

      The objective of this study is to evaluate the efficacy and safety of lorcaserin in the
      treatment of cocaine use disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a DSM-5 diagnosis of current cocaine use disorder as verified by the Structured
             Clinical Interview for DSM-5

          -  Is seeking treatment for cocaine use disorder

          -  Is able to understand and provide written informed consent

          -  Has used cocaine on at least 1 day in the last 30 days prior to screening

          -  Has completed all psychological assessments and procedures during the screening period

          -  If female, not pregnant, lactating, unable to conceive OR must agree to use an
             acceptable method of birth control

          -  Has a total body weight greater than 110 pounds and body mass index greater than 20

        Exclusion Criteria:

          -  Contact site for more information
IN Sub-Dissociative Ketamine vs IN Fentanyl
Condition: Bone Fracture
MeSH terms: Fractures, Bone
Intervention: ketamine; fentanyl; ibuprofen or acetaminophen
Intervention description: intranasal (IN) sub-dissociative ketamine (1mg/kg); Intranasal (IN) fentanyl (1.5 micrograms/kg); 10 mg/kg of ibuprofen or 15 mg/kg of acetaminophen will be given to participants prior to the randomized intervention
Intervention MeSH terms: Acetaminophen; Ibuprofen; Fentanyl; Ketamine; Analgesics
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 87.0
Sex: All
Minimum age: 4 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This single center, randomized control, double blind trial will prospectively examine the
      feasibility of intranasal, sub-dissociative (IN) ketamine versus intranasal fentanyl for pain
      control in the pediatric emergency department setting. The investigators hypothesize that IN
      ketamine may provide a safe and effective alternative to IN fentanyl for children with
      suspected, isolated extremity fractures.

      Eighty children ages 3-17 years with a suspected, isolated extremity fracture that requires
      analgesia will be randomized to receive IN ketamine or IN fentanyl upon presentation to the
      emergency department and will be followed for 2 hours for efficacy and 6 hours for safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  single suspected, isolated extremity fracture that requires analgesia

        Exclusion Criteria:

          -  GCS < 15 at ED presentation,

          -  reported allergy or adverse reaction to ketamine or fentanyl,

          -  pregnancy,

          -  intoxication,

          -  hypotension (less than 70 mmHg +2x age or less than 90 mm Hg for patients greater than
             11 years of age)

          -  weight > 70 kg

          -  patients receiving opioid analgesia administered prior to arrival

          -  multiply injured patients (injuries to multiple extremities)

          -  aberrant nasal anatomy that precludes IN medications