bioihbjkbjnl/mcl2 huggingface dataset:
Study of Cetuximab With and Without Weekly Paclitaxel for Patients With Previously Treated Advanced Urothelial Cancer
Condition: Urologic Neoplasm
MeSH terms: Urologic Neoplasms
Intervention: Cetuximab; Paclitaxel
Intervention description: Cetuximab 250mg/m2 IV weekly for each 28 day cycle.; Paclitaxel 80mg/m2 IV weekly for each 28 day cycle.
Intervention MeSH terms: Paclitaxel; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: urothelial; urologic; neoplasm; advanced; metastatic

Summary:

      The purpose of this research study is to determine whether the investigational drug
      cetuximab, (Erbitux) alone or with paclitaxel (Taxol) can stabilize the growth of urothelial
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed carcinoma of the urothelium (bladder,renal pelvis, ureter)

          -  Measurable disease by RECIST

          -  Patients who received only one prior systemic non-taxane regimen for urothelial
             cancer. May have received this in the adjuvant or neoadjuvant setting or for advanced
             disease.

          -  Signed IRB approved consent

          -  Must have tissue available for EGFR assessment and additional correlative studies

          -  ECOG PS 0-2

          -  18 years of age or older

          -  Not of child bearing potential or negative pregnancy test within 7 days of treatment

          -  ANC greater than or equal to 1,500/ul

          -  Platelets greater than or equal to 100,00/ul

          -  Creatinine less than or equal to 2x institutional ULN or create. clearance greater
             than or equal to 30, bilirubin less than or equal to 1.5x ULN, AST&ALT less than or
             equal to 5x ULN

        Exclusion Criteria:

          -  Received more than one prior regimen for advanced disease

          -  Prior radiation to more than 30% of marrow containing skeleton

          -  Prior therapy that specifically and directly targets the EGFR pathway

          -  Prior severe infusion reaction to a monoclonal antibody, pre-existing neuropathy
             greater than or equal to grade 2

          -  Prior reaction to Cremophor EL

          -  Known acute hepatitis B or C or known HIV

          -  Active or uncontrolled infection

          -  Significant history of uncontrolled cardiac disease

          -  Any concurrent chemotherapy not indicated in this study; or

          -  Any other investigational agents
Oxytocin, Alcohol Craving, and Intimate Partner Aggression
Condition: Alcohol Use
MeSH terms: Aggression
Intervention: Oxytocin; Placebo
Intervention description: 40 IU oxytocin nasal spray; Saline
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Couples; Oxytocin; Aggression; Alcohol

Summary:

      Alcohol use disorders (AUD) and intimate partner aggression (IPA) frequently co-occur. There
      are significant health and economic burdens associated with AUD and co-occurring IPA, and
      little empirical data to guide treatment efforts. The neuropeptide oxytocin may help mitigate
      both AUD and IPA. However, clinical data examining oxytocin's effects on human aggression is
      scant. The proposed study is designed to address these gaps in the literature by utilizing a
      human laboratory paradigm to test the effects of oxytocin on craving and aggression among
      couples with AUD and co-occurring IPA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inclusion criteria indicate that participants must

          -  aged 18 or over

          -  fluent in English

          -  endorse at least one instance of mild or moderate physical IPA with their partner in
             the past 6 months as defined by the Revised Conflict Tactics Scale (CTS-2)

          -  both partners must be willing to participate

          -  one or both partners must meet Diagnostic and Statistical Manual of Mental Disorders
             (DSM-V) criteria for an alcohol use disorder (AUD). Concurrent substance use disorders
             (e.g., marijuana) is acceptable provided alcohol is the participant's primary
             substance of choice.

        Exclusion Criteria:

          -  Exclusion criteria include

          -  pregnancy or breastfeeding

          -  current or history of psychiatric or medical condition that could interfere with
             neuroendocrine function (e.g., hematological, endocrine, renal, or pulmonary disease;
             synthetic glucocorticoid or exogenous steroid therapy; psychotic, bipolar, eating
             disorders)

          -  Body Max Index (BMI) ≥ 39

          -  current suicidal ideation and intent

          -  severe physical or sexual IPA in the past six months as defined by the Conflict
             Tactics Scale (CTS-2)

          -  initiation of psychotropic medication in the past 4 weeks

          -  acute alcohol withdrawal as indicated by a score of 8 or greater on the Clinical
             Institute Withdrawal Assessment of Alcohol Scale (CIWA-Ar).
Rasagiline Rescue in Alzheimer's Disease Clinical Trial
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Rasagiline; Placebo
Intervention MeSH terms: Rasagiline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 50 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      This is a Phase II, randomized, double blind, placebo controlled, parallel group, proof of
      concept three-site study, to evaluate the effect of Rasagiline in the regional brain
      metabolism on 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG-PET).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females 50 to 90 of age inclusive.

          -  Diagnosis of probable AD (NINCDS-ADRDA criteria)

          -  Positive fluoro-deoxyglucose PET ([18F]-FDG PET) scan compatible with AD as determined
             by the ADM Diagnostics LLC (ADMdx) Criteria at screening

          -  Mini Mental Status Exam = 12 - 22 (inclusive)

          -  Must have a study partner who is able and willing to comply with all required study
             procedures.

          -  Have at least eight years of education and should have previously (in pre-AD
             condition) been capable of reading, writing, and communicating effectively with others
             in English.

          -  If receiving therapy with a cholinesterase inhibitor and/or memantine, the dose of
             these agents has been stable for at least 3 months prior to screening

        Exclusion Criteria:

          -  Any non-AD neurological disease

          -  MRI findings indication of a non-AD diagnosis

          -  Screening laboratory studies that are 1.5 times above or below the highest and lowest
             range of normal for each test respectively

          -  History of melanoma; history of malignancy within the past five years with the
             exception of basal cell or squamous cell cancer, in-situ cervical cancer, or localized
             prostate cancer
A Long Term Study to Assess the Safety of Fostamatinib in Patients in Asia With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Fostamatinib
Intervention description: Fostamatinib 100mg once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 115.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis

Summary:

      The purpose of this study is to evaluate the long term safety and tolerability of
      fostamatinib in patients in Asia with rheumatoid arthritis (RA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of informed consent prior to any study-specific procedures.

          -  Patients who have successfully completed study D4300C00008 and whose disease is
             adequately controlled, in the opinion of the Investigator.

        Exclusion Criteria:

          -  Premature withdrawal from study D4300C00008 or in the opinion of the Investigator the
             patient's disease is not adequately controlled on current treatment.

          -  Development of any of the withdrawal criteria from study D4300C00008

          -  Females who are pregnant or breast feeding

          -  Any other clinically significant disease or disorder, which in the opinion of the
             Investigator might put the patient at risk due to participation in the study, or may
             influence the results of the study
A Study of Avastin (Bevacizumab) in Combination With Standard Therapy in Patients With Metastatic Renal Cell Cancer.
Condition: Renal Cell Cancer
MeSH terms: Carcinoma, Renal Cell
Intervention: bevacizumab [Avastin]; Interferon alfa-2a; Vinblastine
Intervention description: 15mg/kg iv every 3 weeks; 3 MioIU sc escalating to 18 MioIU sc, 3 times weekly; 0.1mg/kg iv every 3 weeks
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Bevacizumab; Vinblastine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the efficacy and safety of Avastin in combination with
      interferon alfa-2a and vinblastine as first line treatment in patients with metastatic renal
      cell cancer. Patients will receive Avastin (15mg/kg iv) every 3 weeks, interferon alfa-2a 3
      times weekly (3 Mio IU sc escalating to 18 Mio sc) and vinblastine (0.1mg/kg iv) every 3
      weeks. The anticipated time on study treatment is until tumor progression, and the target
      sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  metastatic renal cell cancer of predominantly clear cell type;

          -  >=1 measurable lesion.

        Exclusion Criteria:

          -  prior treatment with chemotherapy, cytokine or tyrosine kinase inhibitor therapy for
             metastatic renal cell cancer;

          -  ongoing or recent need for full therapeutic dose of anticoagulants or chronic daily
             treatment with aspirin (>325mg/day);

          -  clinically significant cardiovascular disease.
N-Acetylcysteine for Pediatric Trichotillomania
Condition: Trichotillomania; Hair Pulling
MeSH terms: Trichotillomania
Intervention: N-Acetylcysteine; Placebo
Intervention description: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks; placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 39.0
Sex: All
Minimum age: 8 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Trichotillomania; Hair pulling; glutamate; N-Acetylcysteine; Children

Summary:

      Trichotillomania (hair pulling) has an estimated lifetime prevalence of 1-3%. Children with
      trichotillomania can experience significant impairment due to peer teasing, avoidance of
      activities (such as swimming and socializing), difficulty concentrating on school work and
      medical complications due to pulling behaviors. Despite the fact that trichotillomania has a
      childhood onset, no randomized, controlled trials have been completed in childhood
      trichotillomania.

      Research in adults with trichotillomania has demonstrated that most commonly currently
      prescribed treatment for trichotillomania, (pharmacotherapy with selective serotonin reuptake
      inhibitors) is ineffective in treating this condition. By contrast, randomized controlled
      trials in adults have suggested the efficacy of N-acetylcysteine as well as behavioral
      treatments such as Habit Reversal Therapy.

      The goal of this trial is to determine the efficacy of N-Acetylcysteine for pediatric
      trichotillomania. N-Acetylcysteine is a glutamate modulating agent, with a fairly benign
      side-effect profile.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children aged 8-17 years.

          -  Primary DSM-IV diagnosis of trichotillomania or chronic hair pulling.

          -  Duration of trichotillomania greater than 6 months.

        Exclusion Criteria:

          -  Comorbid bipolar disorder, psychotic disorder, substance use disorder, developmental
             disorder or mental retardation (IQ<70).

          -  Recent change (less than 4 weeks) in medications that have potential effects on TTM
             severity (such as SSRIs, CMI, naltrexone, lithium, psychostimulants, anxiolytics, or
             antipsychotics). Medication change is defined to include either dose changes or
             medication discontinuation.

          -  Asthma requiring medication use within the last 6 months.

          -  Known hypersensitivity or previous anaphylactoid reaction to acetylcysteine or any
             components in its preparation

          -  Current use (within last week) of psychostimulant medications.

          -  Positive pregnancy test or drug screening test
Safety and Efficacy of USB002 for Respiratory Distress Due to COVID-19
Condition: 2019 Novel Coronavirus Infection; COVID-19 Virus Infection; SARS Coronavirus 2 Infection; SARS-CoV-2 Infection; Respiratory Distress Syndrome, Adult; Adult Respiratory Distress Syndrome
MeSH terms: Infections; Communicable Diseases; COVID-19; Coronavirus Infections; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Intervention: USB002; Placebo
Intervention description: USB002 is pharmaceutically formulated Angiotensin 1-7 [A(1-7)], a non-hypertensive derivative of Angiotensin-II (A-II), and is suspended in a vehicle as a sterile solution of USB002. Depending upon cohort assignment, subjects in the USB002 group will receive one of four doses of USB002 administered intravenously (IV).; The placebo formulation will be the USB002 formulated solution without the addition of A(1-7). The placebo will be administered intravenously (IV).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial will study the use of USB002 given as an intravenous infusion in patients with
      respiratory distress due to infection with COVID-19.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed informed consent from patient or legal representative;

          2. Age 18 or greater;

          3. Positive reverse transcription polymerase chain reaction (RT-PCR) for SARS-CoV-2 (≤10
             days);

          4. Respiratory rate > 20 RR;

          5. SpO2 < 94% on room air, requiring supplemental oxygen, requiring invasive mechanical
             ventilation, or requiring ECMO;

          6. Chest X-ray confirming bilateral pulmonary infiltrates;

          7. Body mass index of ≤ 40 units/kg/m2;

          8. Adequate method of birth control.

        Exclusion Criteria:

          1. Terminally ill patients due to underlying cardiac, cancer or severe debilitating
             neurological disease including coma;

          2. Hospitalization expected to be < 96 hours due to medical improvement;

          3. Interstitial lung disease;

          4. Correction of QTc values obtained by 12 lead EKG using Fredericia's formula (QTcF) >
             450 ms;

          5. History of hypotension (mean arterial blood pressure < 65 mmHg), unrelated to CoVID-19
             infection;

          6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times upper
             limit of normal;

          7. Participating concurrently on another clinical trial for the experimental treatment of
             COVID-19;

          8. Active chemotherapy use;

          9. Pregnant and/or lactating women.
Neoadjuvant GW572016 to Treat Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: GW572016; lapatinib
Intervention description: Lapatinib, 500 mg; Lapatinib 500 mg PO
Intervention MeSH terms: Lapatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced; Breast; Cancer; Neoadjuvant; HER2

Summary:

      We want to learn whether GW572016 is effective in breast cancers that have HER2.
    

Eligibility criteria:

        Inclusion Criteria:

          1. All patients must be female.

          2. Signed informed consent.

          3. Locally advanced breast cancers or primary breast cancers with concomitant gross
             metastatic disease are eligible. Locally advanced cancers must be of clinical and/or
             radiologic size >/- 5 cm, and/or are deemed surgically inoperable, with Stage IIIb,
             IIIc, or IV disease.

          4. HER2 overexpressing tumors defined as HercepTest score of 3+, or >/- 10% cells
             moderately or strongly HER2 positive by other methods, or semi-quantitative score of
             >/- 5 (in Dr. Allred's laboratory) or gene amplified.

          5. Negative serum pregnancy test (BHCG) within 7 days of starting study, if of
             child-bearing potential.

          6. Kidney and liver function tests - all within 1.5 times the institution's upper limit
             of normal.

          7. Performance status (WHO scale) less than 2 and life expectancy greater than 6 months.

          8. Age greater than 18 years.

          9. No brain or leptomeningeal disease.

         10. No previous or current malignancies at other sites within the last 5 years, with
             exception of adequately treated core-biopsied in situ carcinoma of the cervix uteri
             and basal or squamous cell carcinoma of the skin.

        Exclusion Criteria:

          1. Pregnancy or unwillingness to use a reliable contraceptive method in women of
             child-bearing potential.

          2. Severe underlying chronic illness or disease.

          3. Cardiomyopathy or baseline LVEF <50%.

          4. Other investigational drugs while on study.

          5. Severe or uncontrolled hypertension, history of congestive heart failure or severe
             coronary arterial disease.

          6. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
             resection of the stomach or small bowel. Subjects with ulcerative colitis are also
             excluded.

          7. Taking any GW572016-prohibited medication (see GW572016 Prohibited Medications List in
             protocol) within 7 days of first dose of study medications.
A Study of Abemaciclib (LY2835219) In Participants With Previously Treated Breast Cancer That Has Spread
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Abemaciclib
Intervention description: Administered orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 132.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Endocrine Therapy, Taxane, MONARCH 1

Summary:

      The main purpose of this study is to evaluate whether the study drug known as abemaciclib is
      effective in treating participants with breast cancer who have already tried other drug
      treatments.
    

Eligibility criteria:

        Inclusion Criteria.

          -  Have a diagnosis of Hormone Receptor Positive (HR+), Human Epidermal Growth Factor
             Receptor 2 Negative (HER2-) breast cancer.

          -  Recurrent, locally advanced, unresectable or metastatic breast cancer with disease
             progression following anti-estrogen therapy.

          -  Prior treatment with at least 2 chemotherapy regimens:

               -  At least 1 of these regimens must have been administered in the metastatic
                  setting.

               -  At least 1 of these regimens must have contained a taxane.

               -  No more than 2 prior chemotherapy regimens in the metastatic setting.

          -  Have a performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology Group
             scale.

          -  Have discontinued all previous therapies for cancer.

          -  Have the presence of measureable disease as defined by Response Evaluation Criteria in
             Solid Tumors Version 1.1.

        Exclusion Criteria:

          -  Have either a history of central nervous system (CNS) metastasis or evidence of CNS
             metastasis on the magnetic resonance image of brain obtained at baseline.

          -  Received prior therapy with another cyclin-dependent kinases 4 and 6 (CDK4/6)
             inhibitor.

          -  Have received treatment with a drug that has not received regulatory approval for any
             indication within 14 or 21 days of the initial dose of study drug.

          -  Have had major surgery within 14 days of the initial dose of study drug.

          -  Have a history of any other cancer (except non-melanoma skin cancer or carcinoma
             in-situ of the cervix).