bioihbjkbjnl/mcl2 huggingface dataset:
Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Ketoconazole, Hydrocortisone and Dutasteride
Intervention description: Ketoconazole: 200mg orally three times a day on an empty stomach. Hydrocortisone: 30mg in the morning and 10mg in the evening. Pills should be taken with food or milk.
Dutasteride: 0.5mg orally once a day on an empty stomach or after eating a meal
Intervention MeSH terms: Ketoconazole; Hydrocortisone; Dutasteride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hormone refractory; KHAD; ketoconazole; dutasteride; hydrocortisone

Summary:

      The combination of ketaconazole and hydrocortisone is commonly used for the treatment of
      prostate cancer. The purpose of this study is to determine if the addition of a drug called
      dutasteride to this approved combination will make the combination more effective in treating
      prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically documented evidence of prostate cancer (needle biopsy or
             prostatectomy). In the abscence of histologically documented evidence of prostate
             cancer, the diagnosis must be based on elevated serum PSA and metastatic lesions on
             bone scan.

          -  Progressive HRPC defined as a PSA increase over baseline of >25% or 5ng/ml or new
             lesions on bone/CT scan after conventional androgen deprivation and antiandrogen
             withdrawal. Evidence of metastatic disease based on positive CT or bone scan is not
             required.

          -  PSA of greater than or equal to 2ng/ml and serum total testosterone less than or equal
             to 50ng/ml

          -  Prior chemotherapy is permitted if discontinued > 4 weeks prior to starting therapy

          -  Prior therapy with estrogens is permitted but must have been discontinued > 4 weeks
             prior to registration

          -  ECOG Performance Status 0-2

          -  Adequate renal function, hepatic function, and bone marrow function as outlined in
             protocol

          -  ECG showing a normal QT interval

        Exclusion Criteria:

          -  Prior therapy with ketoconazole or corticosteroids for HRPC

          -  Major surgery or radiation therapy within 4 weeks

          -  Strontium-89 or samarium-153 therapy within 4 weeks

          -  Thromboembolism in past 6 months

          -  Patients who are taking drugs that may further prolong QT intervals and present a
             known risk for Torsades de Pointes.

          -  Concomitant use of drugs known to be narrow therapeutic index CTP3A4

          -  Drugs that are sensitive CYP3A4 substrates

          -  Alcohol or drug dependence currently or in the last 6 months
A Study of Herceptin (Trastuzumab) in Combination With Xeloda (Capecitabine) in Patients With Metastatic or Recurrent HER2-positive Breast Cancer After First-Line or (Neo)Adjuvant Therapy.
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: capecitabine [Xeloda]; trastuzumab [Herceptin]
Intervention description: 900mg/m2 bid po on days 1-14 of each 3-week cycle; 8mg/kg iv on day 1 of the first 3-week cycle, followed by 6mg/kg iv every 3 weeks
Intervention MeSH terms: Capecitabine; Trastuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This single arm. open-label study will assess the efficacy and safety of Herceptin
      (trastuzumab) in combination with Xeloda (capecitabine) in patients with metastatic or
      recurrent HER2-positive breast cancer, refractory to or relapsing after chemotherapy with
      Herceptin and taxanes. Patients will receive Xeloda 900mg/m2 twice daily orally on days 1-14
      of each 3-week cycle and Herceptin 8mg/kg intravenously (iv) on day 1 of the first cycle
      followed by 6mg/kg iv every 3 weeks. The anticipated time on study treatment is until disease
      progression or unacceptable toxicity occurs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female patients, 18-65 years of age

          -  Histologically confirmed HER2-positive breast cancer with measurable lesions
             (according to RECIST criteria)

          -  Metastatic disease after first-line therapy or recurrent disease after (neo)adjuvant
             therapy with Herceptin and taxanes

          -  ECOG performance status 0-2

        Exclusion Criteria:

          -  CNS metastases which are not well controlled

          -  Simultaneous treatment with sorivudine

          -  History of another malignancy within the last 5 years except for cured basal cell
             carcinoma of the skin and cured carcinoma in-situ of the uterine cervix

          -  Pregnant or lactating women
A Study in Participants With Diabetic Kidney Disease
Condition: Diabetic Kidney Disease; Diabetic Nephropathy; Diabetic Glomerulosclerosis
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Intervention: LY2382770; Placebo
Intervention description: Subcutaneous injection given monthly for 12 months; Subcutaneous injection given monthly for 12 months
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 417.0
Sex: All
Minimum age: 25 Years
Healthy volunteers: No
Keywords: Chronic Kidney Disease; Diabetic Kidney Disease; End-Stage Renal Disease; Transforming Growth Factor beta 1 Monoclonal Antibody; Type 1 Diabetes; Type 2 Diabetes

Summary:

      The purpose of this study is to determine if LY2382770 is safe and effective at protecting
      kidney function in participants with kidney disease due to diabetes.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Participants with chronic kidney disease presumed due to diabetes Type 1 or Type 2

          -  Participants with certain levels of kidney function - serum creatinine (SCr) 1.3 to
             3.3 mg/dl (115 to 291 micromol/L) inclusive for women and 1.5 to 3.5 mg/dl (132 to 309
             micromol/L) inclusive for men, or an estimated glomerular filtration rate (eGFR) 20 to
             60 mL/min/1.73 m²

          -  Participants with protein in the urine - 24-hour urine protein/creatinine ratio (PCR)
             greater than or equal to 800 mg/g (greater than or equal to 91 mg/mmol).

          -  Participants must be on a stable and acceptable dose of an ACE (angiotensin-converting
             enzyme) inhibitor or an ARB (angiotensin II receptor blocker), or not able to tolerate
             these medications.

        Main Exclusion Criteria:

          -  Female participants who can become pregnant, are pregnant or breastfeeding

          -  Participants who have any of the following medical conditions (the site research staff
             will discuss these criteria and determine a participant's ability to participate)

               -  Chronic inflammatory or autoimmune diseases

               -  Chronic Kidney Disease from causes other than diabetes

               -  An organ transplant

               -  Too high a blood pressure

               -  Viral Hepatitis B or C liver infection, liver cirrhosis, or significant liver
                  disease

               -  Recent gastrointestinal bleeding

               -  Acute kidney injury within the 3 months before screening

               -  Major surgery within 3 months before screening or plan to have it during the
                  study period

               -  HIV infection- the virus that causes AIDS

               -  Heart disease that is not considered stable

               -  Cancer that is too recent or other condition which poses too high a risk for
                  developing cancer

               -  Required to take drugs that change the immune system
Bioavailability, Safety and Tolerability of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat®)
Condition: Refractory Epilepsy
MeSH terms: Epilepsy; Drug Resistant Epilepsy
Intervention: diazepam nasal spray; diazepam rectal gel
Intervention MeSH terms: Diazepam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 78.0
Sex: All
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Seizures; Epilepsy

Summary:

      This is a multi-center, open-label, crossover, pharmacokinetic, bio-availability study
      involving adolescents and adults with refractory (drug-resistant) epilepsy. Cohort 1
      comprises the subjects used to determine the relative bioavailability of DZNS versus DRG
      (Diastat)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of refractory epilepsy

          -  Body weight 26 to 111 kilogram (kg) inclusive

          -  Other inclusion criteria apply

        Exclusion Criteria:

          -  Male or female subject who is not surgically sterile or female subject who is less
             than 2 years postmenopausal, and does not agree to use a highly effective birth
             control method during the study and up to 3 months after the last dose of
             investigational product

          -  Female subject who is pregnant, breastfeeding, or planning to become pregnant

          -  Presence or history of any abnormality or illness that may affect the absorption,
             distribution, metabolism or elimination of diazepam

          -  Other exclusion criteria apply
Trial Of PF-00299804 In Patients With Advanced Refractory Lung Cancer
Condition: Carcinoma, Non Small Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: PF-00299804
Intervention description: Single arm (no comparator) study, oral once daily dosing, dose escalation (it is a phase 1/2 study) until disease progression, unacceptable toxicity or withdrawal of consent
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To assess the safety and efficacy of PF-00299804 in patients with advanced lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced NSCLC

          -  Prior treatment with and failure of at least one regimen of chemotherapy and erlotinib
             or gefitinib

          -  Prior treatment with no more than two chemotherapy regimens, including adjuvant
             treatment

          -  Measurable disease

        Exclusion Criteria:

          -  Chemotherapy, radiotherapy, biological or investigational agents within 4 weeks of
             baseline disease assessment

          -  Patients who lack of tolerance of erlotinib therapy

          -  Patients with known brain Metastases

          -  Patients with demonstrated history of or presence of interstitial lung disease.
Tarceva And Radiotherapy in Locally Advanced Lung Cancer Non-small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Tarceva; Radiotherapy
Intervention description: Tarceva 150 mg/day; 66 Gy/33 F/5 F per week for 5 weeks
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Lung cancer; Non-small cell lung cancer; Tarceva; Radiotherapy; Local-regionally advanced non-small cell lung cancer

Summary:

      The trial is a phase II study of daily Tarceva combined with definitive radiotherapy in
      inoperable locally advanced non small cell lung cancer (stage IIB-IIIB). The objective of the
      phase II trial is to examine Tarceva concomitant with curatively intended irradiation 66 Gy
      (2 Gy x 33 F, 5 F per week).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥18 years

          -  Patients with histologically or cytologically documented diagnosis locally advanced
             NSCLC stage IIB to IIIB without pleural effusion

          -  Performance status ≤2 on the ECOG scale

          -  Serum bilirubin must be ≤1.5 upper limit of normal (ULN)

          -  ALAT ≤2 x ULN

          -  Able to comply with study and follow-up procedures

          -  Patients with reproductive potential must use effective contraception

          -  Written (signed) informed consent to participate in the study

        Exclusion Criteria:

          -  Any unstable systemic disease (including active infection, unstable angina, congestive
             heart failure, severe hepatic, renal, or metabolic disease)

          -  Any other malignancies within 5 years (except for adequately treated carcinoma in situ
             of the cervix or basal or squamous cell skin cancer)

          -  Inability to take oral medication, or requirement of intravenous alimentation

          -  Nursing mothers
Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: Paclitaxel
Intervention description: Solution, I.V., 100 mg/m2 Weekly for 6 of 7 weeks, Until disease progression or unacceptable toxicity became apparent
Intervention MeSH terms: Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this study is to provide access to paclitaxel therapy to subjects with
      advanced head and neck cancer who have completed the previous late phase 2 study (CA139-388)
      and should have continued therapy with paclitaxel as the discretion of the investigator, and
      to evaluate the frequency and the severity of observed adverse reactions in treated subjects
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with advanced head and neck cancer who have completed the previous late phase
             2 study (CA139-388) and should have continued therapy with paclitaxel as the
             discretion of the investigator
Imaging GABAergic/Glutamatergic Drugs in Bipolar Alcoholics Alcoholics
Condition: Alcohol Use Disorder; Bipolar Disorder
MeSH terms: Alcoholism; Bipolar Disorder
Intervention: N-Acetylcysteine; Gabapentin; Placebo Oral Tablet
Intervention description: 5 day trial of N-acetylcysteine with titration to 2,400mg; 5 day trial of gabapentin with titration to 1,200mg; 5 day trial of matched placebo
Intervention MeSH terms: Acetylcysteine; Gabapentin; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-Blind
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The proposed 3-week, double-blind, crossover, proof of concept study aims to manipulate
      neurochemical dysfunctions characteristic of individuals with co-occurring BD and AUD (i.e.,
      abnormally low prefrontal GABA and glutamate), using medications that have been shown to
      normalize cortical GABA (i.e., gabapentin) and glutamate (i.e., NAC) levels in past research,
      and to evaluate medication-related changes in response inhibition and alcohol cue-reactivity
      fMRI tasks as well as drinking and mood in individuals with AUD+BD.
    

Eligibility criteria:

        Inclusion:

          -  Meets DSM-V diagnostic criteria for Bipolar Disorder

          -  Using at least one mood stabilizing medication

          -  Meets diagnostic criteria Alcohol Use Disorder, with active drinking in the past
             month.

        Exclusion:

          -  Serious medical or non-inclusionary psychiatric disease

          -  Concomitant use of benzodiazepine medications or any medications hazardous if taken
             with gabapentin/N-acetylcysteine

          -  History of clinically significant brain injury

          -  Presence of non-MRI safe material, or clinically significant claustrophobia.
A Phase II Study of Cabozantinib (XL184) Therapy in Castrate Resistant Prostate Cancer (CRPC) With Visceral Metastases
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms; Neoplasm Metastasis
Intervention: Cabozantinib
Intervention description: Cabozantinib 60 mg daily (oral). Subjects may continue to receive study treatment until they experience unacceptable drug-related toxicity or disease progression.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: liver metastasis; lung metastasis; metastatic castrate-resistant; prostate cancer

Summary:

      This research study is being done to measure the clinical benefit associated with
      cabozantinib (XL184) in men who have prostate cancer that has spread to visceral organs
      (organs other than bone or lymph nodes) and no longer responds to initial hormonal
      (castration) therapy. This type of prostate cancer is called metastatic, castrate-resistant
      prostate cancer.
    

Eligibility criteria:

        KEY INCLUSION CRITERIA

        - mCRPC that includes visceral disease. Visceral metastatic disease is defined as solid
        organ infiltration that is not bone or lymph node metastases.

        KEY EXCLUSION CRITERIA

          -  Recent history (<6 months) of gastrointestinal hemorrhage requiring blood transfusion.

          -  Tumor involvement in the intestinal lining which the treating physician deems at risk
             for perforation with rapid tumor response.
Evaluate SAGE-547 in Female Participants With Severe Postpartum Depression
Condition: Postpartum Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Intervention: SAGE-547
Intervention description: Intravenous injection
Intervention MeSH terms: Brexanolone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Postpartum depression

Summary:

      This is an open-label proof-of-concept study designed to evaluate the safety, tolerability,
      pharmacokinetics (PK), and efficacy of SAGE-547 Injection in adult female participants
      diagnosed with severe postpartum depression (PPD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult females, 18-45 years old who experienced a major depressive episode in the
             postpartum period beginning within the first 4 weeks following delivery

          -  Participant has ceased lactating, or if still lactating has already fully and
             permanently weaned their infant; if still actively breastfeeding, participant must
             agree to cease giving breast milk to their infant prior to study entry

        Exclusion Criteria:

          -  Recent history or active clinically significant manifestations of metabolic, hepatic,
             renal, hematological, pulmonary, cardiovascular, gastrointestinal, musculoskeletal,
             dermatological, urogenital, or eyes, ears, or nose and throat (EENT) disorders

          -  Active psychosis

          -  Medical history of seizures
A Dose-finding Study of OPC-6535 in Patients With Active Crohn's Disease
Condition: Crohn Disease
MeSH terms: Crohn Disease
Intervention: OPC-6535(Tetomilast)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 29.0
Sex: All
Minimum age: 16 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: OPC-6535; Crohn's disease

Summary:

      The purpose of this study to examine the safety and efficacy of OPC-6535 and determine its
      optimal dose by once-daily oral administration at 0, 25, or 50 mg for 8 weeks in combination
      with a fixed oral dose of 5-aminosalicylic acid (5-ASA) or in combination with a fixed oral
      dose of 5-ASA and enteral nutrition in patients with active Crohn's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with active Crohn's disease

          -  Patients who have a primary lesion in either the small intestine or the large
             intestine

          -  Patients who have been receiving an oral 5-ASA formulation at a fixed regimen and at a
             fixed dose

          -  Patients who have either never received enteral nutrition or have been receiving
             enteral nutrition at a fixed intake of 1200 kcal/day or less

          -  Either inpatient or outpatient

        Exclusion Criteria:

          -  Patients who have an external fistula (including anal fistula) in which persistent
             drainage is observed (and who require treatment with antibiotics or synthetic
             antibacterial agents)

          -  Patients with short bowel syndrome (and who require intravenous nutritional support
             due to insufficient intestinal nutrient uptake)

          -  Patients with an artificial anus

          -  Patients who have a complication of serious infectious disease (intra-abdominal
             abscess, etc.)

          -  Patients who have a complication of malignant tumor

          -  Female patients who are pregnant, lactating, or possibly pregnant, or who wish to
             become pregnant during the study period