bioihbjkbjnl/mcl2 huggingface dataset:
Observational Study of Cognitive Outcomes for Subjects Who Have Had Prior PET Amyloid Imaging With Florbetapir F 18 (18F-AV-45)
Condition: Alzheimer's Disease; Mild Cognitive Impairment
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Intervention: florbetapir F 18
Intervention description: 370 Mega Becquerel (10 mCi)
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 152.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Cognitive outcome; 18F-AV-45 PET scan; Amyloid PET scan; Florbetapir F 18 amyloid PET scan; Normal cognition; Change in cognitive status in relation to brain amyloid on PET

Summary:

      The primary objective of this protocol is to determine if brain amyloid imaged with
      florbetapir F 18 (18F-AV-45) PET scans is predictive of progressive cognitive impairment
      during the subsequent 36 months for groups of: normal controls, mild cognitive impairment and
      Alzheimer's disease.

      Hypothesis 1: The probability a subject will experience progressive cognitive impairment
      within 36 months of imaging will be greater in subjects whose 18F-AV-45 PET scan was rated
      amyloid positive compared to subjects whose PET scan was rated amyloid negative.

      The secondary objective is to determine the stability, over 36 months of a clinical
      diagnosis, of AD in patients with an amyloid positive 18F-AV-45 PET.

      Hypothesis 2: The diagnosis of AD will remain unchanged in patients whose PET scan were rated
      as amyloid positive.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All subjects who enrolled in study AV-45-A05(NCT00702143), received 18F-AV-45, and
             completed a PET scan will be eligible to enroll in this trial.

        Exclusion Criteria:
Vitamin B12a Vasoplegic Syndrome
Condition: Vasoplegic Syndrome
MeSH terms: Vasoplegia; Syndrome
Intervention: Hydroxocobalamin; Cardiopulmonary Bypass; Placebos
Intervention description: 5g, IV, Infused once over 15 minutes. The drug comes in a 250ml glass vial with 5g of lyophilized hydroxocobalamin to be reconstituted in 200ml of Normal Saline, Dextrose or Lactated Ringers.; Technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the patient's body.; Placebo is a Normal Saline, 5g, IV, Infused once over 15 minutes. The placebo comes in a 250ml glass vial.
Intervention MeSH terms: Vitamin B 12; Hydroxocobalamin
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Masking and blinding will be carried out by the research pharmacy with unmasking to be performed at study completion through the research pharmacy and statistician.
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Vitamin B12a; Hypotension; Cardiopulmonary Bypass

Summary:

      The study team will evaluate the medication Hydroxocobalamin (B12a) for treatment of low
      blood pressure after cardiac surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any patient for whom we are able to obtain consent ahead of their procedure

          -  Patients presenting for a procedure in which cardiopulmonary bypass will be required

          -  Considered high risk for vasoplegic syndrome

          -  Has no contraindications to arterial line or PA catheter placement

          -  Develops high-dose vasopressors for 30 min or longer and refractory hypotension
             consistent with vasoplegic syndrome within 24 hours of coming off cardiopulmonary
             bypass.

        Exclusion Criteria:

          -  Age<18 years

          -  Known pregnancy or patients without a documented pregnancy test if not menopausal.

          -  Known prior anaphylactic or allergic reaction to B12a

          -  CKD stage 4 or worse

          -  ECMO (extracorporeal membrane oxygenation) prior to study consent.

          -  Patients currently on cardiopulmonary bypass
A Phase II Study of 2 Doses of ZD6474 (Vandetanib) in Combination With FOLFOX vs FOLFOX Alone for the Treatment of Colorectal Cancer
Condition: Colorectal; Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Vandetanib; FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid
Intervention description: once daily oral tablet two dose strengths; intravenous infusion
Intervention MeSH terms: Leucovorin; Folic Acid; Fluorouracil; Oxaliplatin; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 109.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: colorectal; cancer; zactima

Summary:

      The purpose of this study is to determine whether treatment with ZACTIMA (vandetanib) in
      combination with FOLFOX is more effective than FOLFOX alone for colorectal cancer in patients
      who have failed therapy with an irinotecan and fluoropyrimidine containing regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Progression on or following treatment for metastatic colorectal cancer

          -  Have failed therapy with an irinotecan and fluoropyrimidine containing regimen

          -  Have World Health Organisation (WHO) performance status 0-2 and life expectancy >12
             weeks

        Exclusion Criteria:

          -  Previous treatment with small molecule tyrosine kinase inhibitors of VEGFR or EGFR
             Prior monoclonal antibodies are permitted, (eg, cetuximab, bevacizumab)

          -  Previous adjuvant therapy with irinotecan within 12 months of randomisation

          -  More than one prior course of chemotherapy for treatment of metastatic colorectal
             cancer
Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Paclitaxel, carboplatin, temozolomide
Intervention description: Combination chemotherapy was administered for up to 6 cycles
Intervention MeSH terms: Paclitaxel; Carboplatin; Temozolomide
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: 18 Years
Healthy volunteers: No
Keywords: metastatic; melanoma; skin cancer; paclitaxel; carboplatin; temozolomide

Summary:

      The number of melanoma cases has been steadily increasing over the past few decades. For many
      patients with metastatic melanoma, there are no effective therapies. The goal of this study
      is to determine whether a combination drug treatment of carboplatin, paclitaxel and
      temozolomide is effective in the treatment of metastatic or recurrent melanoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients with biopsy proven advanced melanoma are eligible if there is measurable
             disease.

          -  Patients must have a life expectancy of at least 12 weeks.

          -  Prior surgery, immunotherapy, minimal chemotherapy (1 drug for less than 4 months), or
             radiotherapy for primary tumor is acceptable but must be completed at least 4 weeks
             from study entry, and patient should have completely recovered from such procedures.

          -  Patients must have a Zubrod performance status of 0-2.

          -  Patients must sign an informed consent.

          -  Patients should have adequate bone marrow function defined by an absolute peripheral
             granulocyte count of ≥ 1500 cells/mm3, hemoglobin > 8 g/dl, platelet count ≥ 100
             000/mm3.

          -  Patients should have a normal hepatic function with a total bilirubin < 1.5 the upper
             limit of normal (ULN) and serum glutamic oxaloacetic transaminase (SGOT) or serum
             glutamic-pyruvic transaminase (SGPT) < 2 times the upper limit of normal (ULN),and
             adequate renal function as defined by a serum creatinine ≤ 1.5 times the ULN.

          -  Men and women of childbearing potential must be willing to consent to using effective
             contraception while on treatment and at least for 3 months.

          -  Patients with brain metastases are eligible if they have been appropriately treated,
             are asymptomatic

        Exclusion Criteria:

          -  Pregnant women or nursing mothers are not eligible.

          -  Patients must not receive any other concurrent chemotherapy or radiation during this
             trial.

          -  Patients with severe medical problems that would interfere with the therapy are not
             eligible.
RA-4: 13-cis Retinoic Acid for Treatment of Men With Azoospermia
Condition: Male Infertility, Azoospermia
MeSH terms: Infertility; Infertility, Male; Azoospermia
Intervention: 13-cis retinoic acid
Intervention description: Accutane is used for the treatment of severe acne
Intervention MeSH terms: Tretinoin; Isotretinoin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: 20 mg 13-cis retinoic acid twice daily (BID) with meals for 32 weeks
Masking: None (Open Label)
Enrollment: 10.0
Sex: Male
Minimum age: 21 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Infertility

Summary:

      Men with infertility and normal hormone levels have few options for fertility treatment.
      Previous research suggests that men with infertility may have low levels of the active form
      of Vitamin A, called retinoic acid, in their testes. In a pilot study of 20 men with low
      numbers of sperm (<10 million motile sperm), roughly half the men showed improvement in sperm
      production. Thus, we want to see if retinoic acid administration to men with azoospermia (no
      sperm present) can initiate sperm production.
    

Eligibility criteria:

        Inclusion Criteria: Infertile men with azoospermia on at least two semen analyses separated
        by at least one week, and no pregnancy with partner with normal cycles and normal
        hysterosalpingogram despite >1 year of unprotected intercourse.

        -

        Exclusion Criteria: hypogonadotropic hypogonadism (that might respond to gonadotropin
        injections); use of anabolic steroids,illicit drugs, or consumption of more than 4
        alcoholic beverages daily; current therapy with retinoic acid (eg Accutane) or vitamin A-
        of use of isotretinoin within eight weeks of start of dosing;phenytoin, or medication
        containing tetracycline; personal history of serious psychiatric disorders, score of
        greater than 15 on the PHQ9 (mood) questionnaire; elevated serum serum triglycerides or
        other abnormal serum chemistry values; history of inflammatory bowel disease or bone
        disease; not living within catchment area; participation in another clinical trial

        -
Study to Determine the Safety and Efficacy of INCB018424 in Patients With Polycythemia Vera or Essential Thrombocythemia
Condition: Myeloproliferative Neoplasm (MPN)
MeSH terms: Polycythemia Vera; Myeloproliferative Disorders; Polycythemia; Thrombocytosis; Thrombocythemia, Essential
Intervention: Ruxolitinib
Intervention description: Ruxolitinib was administered orally and supplied as 5 mg and 25 mg tablets.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the safety and efficacy profile of different treatment regimens of Ruxolitinib
      (INCB018424) administered to two groups of patients; those with polycythemia vera (PV) and
      those with essential thrombocythemia (ET). Patients in each group were refractory to
      hydroxyurea or for whom hydroxyurea is contraindicated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of polycythemia vera or essential thrombocythemia as determined by
             treating physician

          -  Disease refractory to hydroxyurea or for whom treatment with hydroxyurea is
             contraindicated or have refused further treatment with hydroxyurea due to side
             effects.

          -  Patient meets baseline clinical lab parameters

        Exclusion Criteria:

          -  Treatment with interferon alpha or anagrelide within 7 days and hydroxyurea within 1
             day of starting INCB018424.

          -  Patients diagnosed with another malignancy unless the malignancy was cervical
             intraepithelial neoplasia or basal or squamous cell skin cancer and the patient has
             been disease free for > 3 years

          -  Patients receiving therapy with intermediate or high dose steroids greater than the
             equivalent of 10 mg prednisone per day

          -  Clinically significant cardiac disease (New York Heart Association (NYHA) Class III or
             IV)
An Efficacy, Safety, and Tolerability Study for TA-7284 in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: TA-7284-Low; TA-7284-Low-middle; TA-7284-High-middle; TA-7284-High; Placebo
Intervention description: TA-7284-Low; TA-7284-Low-middle; TA-7284-High-middle; TA-7284-High; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 383.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: TA-7284; JNJ-28431754; Canagliflozin; Type 2 diabetes mellitus; Sodium Glucose Co-transporter (SGLT2 inhibitor)

Summary:

      The purpose of this study is to demonstrate the efficacy, safety, and tolerability of TA-7284
      compared with placebo in patients with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged from 20 to 80 years inclusive on the day of informed consent;

          -  Patients who was diagnosed with type 2 diabetes mellitus at least 3 months before the
             start of the run-in period;

          -  Patients with HbA1c of ≥6.5% and ≤9.5% (according to the Japan Diabetic Society [JDS]
             criteria) on the start day of the run-in period;

        Exclusion Criteria:

          -  Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or
             secondary diabetes mellitus (acromegaly, Cushing's syndrome, etc.);

          -  Past or current history of severe diabetic complications (proliferative diabetic
             retinopathy, stage III or later stage overt nephropathy, diabetic ketoacidosis, or
             serious diabetic neuropathy);

          -  Fasting blood glucose of >270 mg/dL on the start day of the run-in period or at Week 2
             of the run-in period;

          -  eGFR of <60 mL/min/1.73 m2 on the start day of the run-in period;

          -  Systolic blood pressure of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg on the
             start or end day of the run-in period;

          -  History of myocardial infarction, unstable angina, or cerebrovascular disorder within
             3 months before the start of the run-in period;

          -  Concurrent serious (e.g., requiring inpatient hospitalization or surgical
             intervention) renal or hepatic disease;

          -  Past or current history of malignant tumor; however, this criterion shall not apply to
             those who have been free of relapse for at least 5 years even with a history of
             malignant tumor.

          -  Past or current history of drug hypersensitivity such as shock and anaphylactoid
             symptoms;

          -  Pregnant women, lactating mothers, or women of childbearing potential;

          -  Any condition that subjects are assessed to be ineligible by the investigator (sub
             investigator).
BIBW 2992 and Letrozole in Hormonoresistant Metastatic Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: BIBW 2992; BIBW 2992; Letrozole; Letrozole
Intervention description: BIBW 2992 at high and medium dosages; BIBW 2992 at high and medium dosages; Letrozole at standard dosage; Letrozole at standard dosage
Intervention MeSH terms: Letrozole; Afatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 28.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Progression-free rate after 16 weeks of BIBW 2992 administration in association with
      letrozole
    

Eligibility criteria:

        Inclusion criteria:

          -  Female patients with histologically proven breast adenocarcinoma

          -  Presence of metastatic disease No more than 2 prior chemotherapy regimens for
             metastatic disease, which could include trastuzumab Patients must currently be on
             letrozole and developed acquired resistance as defined by disease progression on
             letrozole following previous response (partial response or better, stable disease
             superior or equal to 24 weeks)

        Diagnosis of disease progression inferior or equal to 6 weeks prior to trial entrydefined
        as:

          1. Increase in the number of bone lesions on bone scan or on MRI AND/OR

          2. Increased pain in an area of known bony metastasis AND superior or equal to 2 serial
             elevations in CA 15.3 AND/OR

          3. Progression according to RECIST criteria on CT scan, MRI, or x-ray Patients must have
             documented menopause confirmed by estradiol level inferior to 11 pg/ml

        Exclusion criteria:

          -  Premenopausal patients

          -  Rapidly progressive disease in major organs (i.e. lymphangitic spread in the lung
             and/or bulky liver metastasis) Patient with brain metastasis Significant
             cardiovascular diseases Previous treatment with an EGFR and/or HER-2 inhibiting
             drug(patients who received trastuzumab with chemotherapy but not with letrozole can be
             enrolled)
Study For Patients With Untreated Gastric Cancer Who Will Receive Capecitabine And Lapatinib
Condition: Neoplasms, Gastrointestinal Tract
MeSH terms: Stomach Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms
Intervention: Lapatinib and Capecitabine
Intervention description: oral lapatinib (1250mg) administered as a monotherapy run-in followed by its combination with capecitabine
Intervention MeSH terms: Capecitabine; Lapatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: tumor biopsy; capecitabine; first line; Gastro Esophageal (GE) Junction Cancer; Gastric cancer; newly diagnosed; GE junction; lapatinib; metastatic or unresectable

Summary:

      The study will determine if changes in expression of markers involved in the 5-FU pathways
      are associated with response to treatment with the combination of lapatinib and capecitabine
      independent of tumor erbB2 status.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has signed inform consent

          -  Untreated, newly diagnosed, advanced metastatic or unresectable gastric cancer,
             including the gastro-esophageal junction

          -  Tumor accessible to and patient consent for endoscopic biopsy at study start and after
             7 days of single agent Lapatinib

          -  Measurable disease according to RECIST criteria

          -  Male or female > or = 18 years of age

          -  Cardiac ejection fraction within the institutional range of normal as measured by
             echocardiogram

          -  must have adequate organ function as defined by baseline laboratory values

        Exclusion Criteria:

          -  Gastric carcinoid, sarcomas, or squamous cell cancer

          -  Pregnant or lactating females

          -  Intractable nausea, vomiting, or gastro intestinal obstruction requiring decompression
             and drainage with a gastric tube or nasogastric suction.

          -  patients who require continuous enteral feeding

          -  Malabsorption syndrome or uncontrolled inflammatory GI disease (Crohn's or ulcerative
             colitis

          -  Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart
             failure
Pilot Study of Oxytocin and microRNA Identification in NAF, Serum, and Tissue in Women With Breast Cancer
Condition: Breast Cancer; Ductal Carcinoma in Situ
MeSH terms: Carcinoma; Breast Neoplasms; Carcinoma in Situ; Carcinoma, Ductal; Carcinoma, Intraductal, Noninfiltrating
Intervention: Intranasal Oxytocin
Intervention description: Intranasal spray, one spray or 4 IU of oxytocin will be administered into each nostril of each patient about 15-30 minutes before NAF collection
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast cancer; Ductal carcinoma in situ (DCIS); Oxytocin

Summary:

      The purpose of this study is to examine the genetic material called microRNA of three types
      of specimens from women with breast cancer. The study also seeks to examine the effectiveness
      of using a new agent called oxytocin to increase the amount of nipple fluid that can be
      collected during surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of Ductal carcinoma in situ (DCIS) or invasive breast cancer

          -  Candidate for breast conserving surgery or mastectomy

        Exclusion Criteria:

          -  Pregnant women

          -  Prior Breast Cancer diagnosis

          -  Adverse reaction to Oxytocin in the past