bioihbjkbjnl/mcl2 huggingface dataset:
Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis
Condition: Autoimmune Disorder; Rheumatoid Arthritis; Systemic Lupus Erythematosus; Primary Sjögren's Syndrome
MeSH terms: Arthritis; Arthritis, Rheumatoid; Sjogren's Syndrome; Lupus Erythematosus, Systemic; Autoimmune Diseases; Syndrome
Intervention: branebrutinib; abatacept; branebrutinib placebo
Intervention description: Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Abatacept; Branebrutinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: double-blind
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and effectiveness of treatment with
      branebrutinib treatment in participants with active systemic Lupus Erythematosus (SLE) or
      Primary Sjögren's Syndrome (pSS), or branebrutinib treatment followed by open-label abatacept
      treatment in study participants with active Rheumatoid Arthritis (RA).
    

Eligibility criteria:

        Inclusion Criteria:

        Sub-study for Systemic Lupus Erythematosus (SLE)

          -  Active SLE as defined by the Systemic Lupus Erythematosus International Collaborating
             Clinics (SLICC) classification

          -  Diagnosed with SLE more than 24 weeks before screening visit

        Sub-study for primary Sjögren's Syndrome (pSS)

          -  Moderate to severe pSS, meeting ACR-EULAR classification criteria

        Sub-study for active Rheumatoid Arthritis (RA)

          -  Moderate to severe adult-onset RA

          -  ACR global functional status class I to III

        Women and men must agree to follow instructions for methods of contraception.

        Exclusion Criteria:

        Sub-study for SLE

          -  Certain other autoimmune diseases and overlap syndromes

        Sub-study for pSS

          -  Certain other immune-mediated diseases, active fibromyalgia, or other medical
             conditions

        Sub-study for RA

          -  Diagnosis with juvenile arthritis or idiopathic arthritis before age 16

        For all sub-studies:

          -  History of any significant drug allergy

          -  Active infection, significant concurrent medical condition, or clinically significant
             abnormalities

        Other protocol defined inclusion/exclusion criteria could apply
Phase II Trial of Weekly or Every 3-week Ixabepilone for Patients With Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Ixabepilone; Ixabepilone
Intervention description: Injection, IV, Until progressive disease or intolerable toxicity Ixabepilone 16 mg/m^2 was administered as a 1-hour IV continuous infusion on Days 1, 8, and 15 in a 28-day cycle until progressive disease or intolerable toxicity.; Injection, IV, Until progressive disease or intolerable toxicity Ixabepilone 40 mg/m^2 was administered as a 3-hour IV infusion on Day 1 of each 21-day cycle provided the subject met the retreatment criteria.
Intervention MeSH terms: Epothilones
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 176.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to determine the effects of the weekly regimen of ixabepilone
      dosing compared to the once every 3 week dosing regimen in participants with metastatic
      breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has MBC that is measurable by RECIST or has nonmeasurable disease with serum CA27.29
             (or CA15.3) ≥ 50

          -  Has Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer

          -  Prior chemotherapy is permitted with no limit on the number of prior regimens

          -  Two weeks or more have elapsed since last chemotherapy or radiation treatment

          -  Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2

          -  Is female, ≥ 18 yrs of age

          -  Protocol defined appropriate laboratory values

          -  Negative pregnancy test within 7 calendar days prior to registration

          -  Has signed a patient informed consent

        Exclusion Criteria:

          -  Had prior treatment with ixabepilone or other epothilones

          -  Has HER2+ disease

          -  Has a known, prior, severe (National Cancer Institute Common Terminology Criteria
             Adverse Events [NCI CTCAE] Grade 3-4) history of hypersensitivity reaction to a drug
             formulated in Cremophor ® EL (polyoxyethylated castor oil)

          -  Is receiving concurrent immunotherapy, hormonal therapy or radiation therapy

          -  Is receiving concurrent investigational therapy or has received such therapy within
             the past 30 days

          -  Has peripheral neuropathy > Grade 1

          -  Has evidence of central nervous system (CNS) involvement requiring radiation or
             steroid treatment. Participants with stable brain metastases who are off steroids at
             least 2 weeks are eligible

          -  Is pregnant or breast feeding
A Study of Avastin (Bevacizumab) in Combination With Docetaxel and Cisplatin in Patients With Metastatic or Locally Advanced Non-small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Bevacizumab; Cisplatin; Docetaxel
Intervention description: Bevacizumab was supplied as a sterile liquid in glass vials.; Bevacizumab was supplied as a sterile liquid in glass vials.; Bevacizumab was supplied as a sterile liquid in glass vials.
Intervention MeSH terms: Bevacizumab; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study assessed the efficacy and safety of Avastin in combination with docetaxel and
      cisplatin as first-line treatment of patients with metastatic or locally advanced non-small
      cell lung cancer. Patients received Avastin 15 mg/kg intravenously (IV), docetaxel 75 mg/m^2,
      and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle for a maximum of 6 cycles.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, ≥ 18 years of age.

          -  Stage IIIb or IV non-small cell lung cancer.

          -  Chemotherapy-naive.

        Exclusion Criteria:

          -  Previous treatment for non-small cell lung cancer.

          -  Previous malignant tumor within last 5 years, except for basal cell skin cancer or
             preinvasive cervical cancer.

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to start of study.

          -  Recent or current chronic treatment with aspirin (> 325 mg/day).
Signatures of N-Ac for Non-Suicidal Self-Injury in Adolescents
Condition: Self-Harm; Depression; Suicide
MeSH terms: Suicide; Self-Injurious Behavior
Intervention: N-acetyl cysteine; Placebo oral tablet
Intervention description: 3600 or 5400 mg/day N-acetyl cysteine; Placebo
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 44.0
Sex: Female
Minimum age: 16 Years
Maximum age: 24 Years
Healthy volunteers: No

Summary:

      To measure NAC-induced changes to concentrations of glutathione (GSH) in the anterior
      cingulate cortex (ACC) as measured by magnetic resonance spectroscopy (MRS) in 36 adolescents
      and young adults with NSSI (12 in each group: high, low, and placebo).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current frequency of at least one NSSI episode in the past 2 months

          -  ≥ 5 past episodes of NSSI with significant tissue damage (e.g. scars present)

          -  Psychotropic medications are dose-stable for 1 month

          -  Ability to understand study procedures and to comply with them for the entire length
             of the study

        Exclusion Criteria:

          -  Any MRI contraindications (e.g. metal plates, claustrophobia, braces, implanted
             devices)

          -  Any current serious medical illness as defined by medical history

          -  Current Substance Use Disorder (except Tobacco Use Disorder)

          -  Primary psychotic disorder (e.g. schizophrenia, schizoaffective disorder,
             schizophreniform disorder)

          -  Neurodevelopmental disorder such as mental retardation or autism

          -  Changes in psychotropic medications in past 1 month

          -  Taken NAC or glutathione on a regular basis in the past 6 months

          -  Currently pregnant, planning to become pregnant, currently breastfeeding, or
             unwillingness to use contraception throughout the study.

          -  Allergy/sensitivity to N-acetylcysteine.

          -  Inability or unwillingness of individual or legal guardian/representative to give
             written informed consent.
Concurrent Alcohol and Smoking Treatment: Effects on Alcohol Relapse Risk
Condition: Tobacco Use Cessation; Alcohol-related Disorders
MeSH terms: Recurrence; Alcohol-Related Disorders
Intervention: behavioral counseling plus contingency management
Intervention description: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 151.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: nicotine dependence; tobacco dependence; smoking cessation; alcoholism; self-efficacy; relapse

Summary:

      The majority of individuals with alcohol problems remain current smokers, and the negative
      health consequences of smoking among these individuals are substantial. This study will
      investigate the impact of smoking cessation interventions initiated during intensive alcohol
      treatment on processes reflecting risk of alcohol relapse.
    

Eligibility criteria:

        Inclusion Criteria:

          -  DSM-IV criteria for alcohol abuse or dependence

          -  Age 18 or older

          -  English speaking

          -  Smoking 1 or more cigarettes/day

          -  Male or female veterans eligible for VA healthcare

          -  Female nonveterans also eligible

        Exclusion Criteria:

          -  Allergy or hypersensitivity to nicotine or adhesives used in nicotine patch

          -  Weigh less than 100 lbs

          -  Lack of interest in stopping smoking

          -  Pregnant or lactating females or females not practicing acceptable form of
             contraception
Multiple Doses of AT-1501-A201 in Adults With ALS
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Intervention: AT-1501
Intervention description: AT-1501 monoclonal antibody targeting CD40L given as an IV infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ALS; Lou Gehrig's Disease; motor neuron disease; motor neuron degeneration; AT-1501; humanized blocking antibody to CD40LG; CD40L inhibitor; monoclonal antibody

Summary:

      This is a Phase 2a, multi-center, open label, multiple dose study of AT-1501, a humanized
      monoclonal antibody antagonist to CD40 ligand (CD40L). Approximately 54 adults with
      Amyotrophic Lateral Sclerosis (ALS) will be enrolled into the study in the United States and
      Canada at approximately 13 ALS treatment sites.

      Participants will be enrolled into one of four ascending doses.
    

Eligibility criteria:

        Inclusion Criteria:

          1. ALS diagnosed as possible, laboratory supported probable, probable, or definite as
             defined by revised El Escorial criteria

          2. ALS Functional Rating Scale - Revised (ALSFRS-R) Aggregate score of 37 or greater

          3. No more than 24 months from diagnosis

        Exclusion Criteria:

          1. Any other central or peripheral nervous system disease that may interfere with the
             evaluation of ALS or its progression

          2. Presence of a tracheostomy, or use of permanent assistive ventilation (ventilatory
             support for 23 hours per day or more)

          3. History of malignancy within the previous 5 years, except for localized non-melanoma
             skin cancers

          4. Abnormal function of the immune system resulting from:

               -  Clinical conditions affecting the immune system (e.g. HIV infection,
                  agammaglobulinemia),

               -  Systemic administration of corticosteroids (PO/IV/IM) at a dose equivalent to 20
                  mg/day of prednisone for more than 14 consecutive days within 90 days prior to
                  screening,

               -  Administration of anti-neoplastic and/or immunomodulating agents (e.g. Tumor
                  necrosis factor alpha (TNF α) antagonists or anti-B cell antibodies) or
                  radiotherapy within 1 year prior to screening.

          5. Recipient of Stem Cell or Gene Therapy

          6. Positive test for Hepatitis B surface antigen, Hepatitis C antibody, or HIV.

          7. History of deep venous thrombosis or pulmonary embolism

          8. History of active substance abuse within the past 2 years

          9. History of stroke, poorly controlled or significant cardiovascular disease, diabetes
A Study of Erlotinib (Tarceva) in Participants With Non-Small Cell Lung Cancer (NSCLC)
Condition: Non-Squamous Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Erlotinib
Intervention description: Erlotinib will be administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 264.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess potentially predictive markers of efficacy in participants with NSCLC
      receiving oral erlotinib (Tarceva) therapy. The anticipated time on study treatment is until
      disease progression, unacceptable toxicity or death.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced NSCLC

          -  Tumor accessible for biopsy by bronchoscopy

          -  Disease progression following course of standard chemotherapy, or participants
             unwilling/unable to undergo chemotherapy

        Exclusion Criteria:

          -  Unstable systemic disease

          -  Any other malignancies in the last 5 years

          -  Brain metastases

          -  Previous treatment with therapy acting on the epidermal growth factor receptor (EGFR)
             axis
Safety and Efficacy Study of VP20621 for Prevention of Recurrent Clostridium Difficile Infection
Condition: Clostridium Difficile Infection
MeSH terms: Infections; Communicable Diseases; Clostridium Infections
Intervention: VP20621; VP20621; Placebo; VP20621
Intervention description: VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for seven days; VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for 7 days; 10 mL placebo once daily for 14 days; VP20621 as oral liquid once daily for 14 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 173.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diarrhea; Clostridium difficile; Clostridium infections; Signs and Symptoms Digestive; Bacterial Infections; Pharmacologic Actions

Summary:

      The objectives of this study are: (1) to evaluate the safety and tolerability of VP 20621
      dosed orally for up to 14 days in adults previously treated for CDI; (2) to characterize the
      frequency and duration of stool colonization with the VP 20621 strain of C. difficile; (3) to
      evaluate the efficacy of VP 20621 for prevention of recurrence of CDI; and (4)to select a
      dose regimen of VP 20621 to be used in future studies.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult subjects, 18 years of age and over, who understand the risks and benefits of
             participation and have provided written informed consent for the study.

          2. Subjects who are experiencing a first event or first recurrence of clostridium
             difficile (CDI) within the last 28 days and have been successfully treated with an
             antibiotic for CDI.

          3. Subjects who are medically stable.

          4. Subjects who are willing and able to comply with the study procedures and visit
             schedules outlined.

          5. If female be post-menopausal, surgically sterile or agree to follow an acceptable
             method of birth control.

        Exclusion Criteria:

          1. Subjects who have had more than 2 episodes of CDI within the last 6 months.

          2. Subjects who have been diagnosed with Inflammatory Bowel Disease,active Irritable
             Bowel Syndrome, celiac disease, active gastroparesis, toxic megacolon.

          3. GI surgery within 6 weeks before the day of randomization

          4. Have known immunodeficiency disorder, such as HIV Infection

          5. Pregnant or breast feeding females.

          6. Concurrent acute life-threatening diseases.

          7. Inability to tolerate oral liquids.

          8. Have an absolute neutrophil count < 1000/mm3 at screening
Fulvestrant in Hormone Refractory Prostate Cancer
Condition: Prostatic Neoplasms; Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Fulvestrant
Intervention description: Fulvestrant 250 mg IM on Days 1 and 14 in the first month, thereafter 250 mg monthly
Intervention MeSH terms: Fulvestrant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if treatment with fulvestrant leads to a slowing of
      tumor progression in patients who have developed androgen-independent (AIPC) or
      hormone-refractory prostate cancer (HRPC) and who have a rising serum prostate specific
      antigen (PSA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must give signed written informed consent

          -  Must be of age 18 years or older

          -  Histologically confirmed adenocarcinoma of the prostate

          -  Must be currently receiving LHRH agonists and have castrate levels of testosterone or
             have had an orchiectomy

          -  Must have had rise in PSA despite anti-androgen withdrawal

          -  Must exhibit two consecutive rises in PSA after the last hormonal manipulation

          -  Minimum PSA > 5mg/dL

          -  KPS > 80%

          -  Up to one prior chemotherapy treatments allowed

          -  Life expectancy of greater than 6 months

        Exclusion Criteria:

          -  Concomitant hormonal therapy other than an LHRH

          -  Noncompliance

          -  Platelets less than 100 x 10e9 /L

          -  International normalization ratio (INR) greater than 1.6

          -  Total bilirubin greater than 1.5 x ULRR

          -  ALT or AST greater than 2.5 x ULRR if no demonstrable liver metastases or greater than
             5.0 x ULRR in presence of liver metastases

          -  History of bleeding diathesis (ie, disseminated intravascular coagulation [DIC],
             clotting factor deficiency)

          -  History of long-term anticoagulant therapy (other than antiplatelet therapy)

          -  History of hypersensitivity to active or inactive excipients of fulvestrant (ie,
             castor oil or Mannitol)
CAVATAK in Patients With Stage IIIc or IV Malignant Melanoma to Extend Dosing to 48 Weeks (VLA-008 CALM Ext)
Condition: Melanoma
MeSH terms: Melanoma
Intervention: CVA21
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
Healthy volunteers: No
Keywords: Melanoma; CALM

Summary:

      This is an extended use study for patients who have received 10 doses of CAVATAK™ in the VLA
      007 trial. There may be patients who have benefitted from the study drug and who might
      benefit from further treatment. In order to accommodate those patients further treatment to
      complete 48 weeks of CVA21 intratumoral injections will be made available.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1. Patients must have reached Week 24 of the core protocol in immune-related complete
             response (irCR), immune-related partial response (irPR), immune-related stable disease
             (irSD), or immune-related progressive disease (irPD) (unconfirmed) with evidence of
             tumor inflammatory reaction.

          -  2. If patient is in irPD (unconfirmed) status, they must not have had a decrease in
             their Karnofsky Performances Scale (KPS) score > 10 points and to be judged to not
             have "rapid clinical deterioration" by the investigator since the subject's last tumor
             measurement leading to irPD assessment.

          -  3. Patients must start treatment in the extension protocol within 8 weeks of their
             last injection administered in the core protocol.

          -  4. Patient is able and willing to provide written informed consent to participate in
             the study.

          -  5. Fertile males and females must agree to the use of an adequate form of
             contraception, e.g., condoms for males.

        Exclusion Criteria:

          -  1. Tumors to be injected lying in mucosal regions or close to an airway, major blood
             vessel or spinal cord that, in the opinion of the Investigators, could cause occlusion
             or compression in the case of tumor swelling or erosion into a major vessel in the
             case of necrosis.

          -  2. If lesions are too small to be visualized or palpable for accurate injection.

          -  3. Currently in status of irPD (confirmed) or irPD (unconfirmed) without evidence of
             tumor inflammatory response, or with rapid clinical deterioration, or with a decrease
             of 10 points or more on their KPS score since their last assessment before irPD
             (unconfirmed) assessment.