bioihbjkbjnl/mcl2 huggingface dataset:
Serum Bovine Immunoglobulin Protein Isolate in Improving Quality of Life and Post-Operative Recovery in Patients With Gynecological Cancer After Undergoing Surgery
Condition: Female Reproductive Cancer
Intervention: serum-derived bovine immunoglobulin protein isolate; placebo; laboratory biomarker analysis; quality-of-life assessment; questionnaire administration
Intervention description: Given PO; Given PO; Correlative studies; Ancillary studies; Ancillary studies
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 58.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized pilot phase II trial studies how well serum bovine immunoglobulin protein
      isolate works in improving quality of life and post-operative recovery in patients with
      cancer of the female reproductive tract after undergoing surgery. Serum bovine immunoglobulin
      may help provide nutrition to patients who are not able to eat or digest ordinary food. This
      may improve the quality of life of patients with gynecological cancer and help them recover
      more quickly from surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of gynecological cancer of any type or strong suspicion for cancer

          -  Patients must have begun postoperative oral intake of food prior to registration

          -  Open laparotomy or laparoscopic surgery undertaken with cancer therapeutic intent (not
             a subsequent surgery to manage a postoperative complication) that had occurred =< 7
             days prior to registration and that entailed more than a simple hysterectomy

          -  Creatinine =< 1.5 x the upper limit of normal (ULN)

          -  Absolute neutrophil count >= 1500/mm^3

          -  Platelet count >= 100,000/mm^3

          -  Ability to complete questionnaire(s) by themselves or with assistance

          -  Provide informed written consent

          -  Negative (serum) pregnancy test done =< 7 days prior to randomization, for women of
             childbearing potential only

          -  Willing to provide mandatory baseline blood samples for correlative research purposes

        Exclusion Criteria:

          -  Symptomatic and/or untreated brain metastases

          -  Ongoing parenteral nutrition (receiving intravenous nutrition support at the time of
             enrollment); note: patients may be receiving maintenance intravenous (IV) fluids

          -  Current enrollment in any other trial that entails the concurrent administration of
             any other agent designed to enhance postoperative recovery

          -  Allergy to beef
Efficacy, Safety, and Tolerability of Eslicarbazepine Acetate in the Recurrence Prevention of Bipolar I Disorder
Condition: Bipolar I Disorder
MeSH terms: Recurrence
Intervention: BIA 2-093 1800 mg once daily [Group 1 (Part II)]; BIA 2-093 900 mg once daily [Group 2 (Part II)]; BIA 2-093 300 mg once daily [Group 3 (Part II)]; BIA 2-093 900 mg (Part I)
Intervention description: BIA 2-093 1800 mg taken orally in the evening, for 2 weeks; BIA 2-093 900 mg taken orally in the evening, for 2 weeks; BIA 2-093 300 mg taken orally in the evening, for 2 weeks.; In Part I, patients received one 900 mg BIA 2-093 tablet once daily, taken orally in the evening, for 2 weeks.
Intervention MeSH terms: Eslicarbazepine acetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 104.0
Sex: All
Healthy volunteers: No
Keywords: bipolar I disorder; Eslicarbazepine acetate; BIA 2-093

Summary:

      This was an extension study consisting of 2 parts. In Part I, all participants received
      open-label treatment with BIA 2-093 900 mg once daily for 2 weeks. Part II followed a
      double-blind, parallel-group design in which participants were randomly assigned to treatment
      with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily. Patients stable in remission continued
      double-blind therapy until approximately 6 months after the last patient entered Part II.
    

Eligibility criteria:

        Inclusion Criteria:

          -  signed the Informed consent form (ICF)

          -  completed the 3-week treatment period in Protocol with identification number
             SCO/BIA-2093-203 or Protocol with identification number PRA/BIA-2093-204 and shown
             response to treatment, defined as ≥ 50% improvement in the Young Mania Rating Scale
             (YMRS) total score or a YMRS total score < 12

          -  presented a serum pregnancy test (in cases of women of childbearing potential)
             consistent with a non-gravid state and used double-barrier contraception throughout
             the study

        Exclusion Criteria:

          -  relevant electrocardiogram (ECG) or laboratory abnormalities

          -  any uncontrolled clinically relevant disorder

          -  uninsured capability to comply with the study protocol
Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome Not Managed by Stable-Dose Octreotide Therapy
Condition: Carcinoid Syndrome
MeSH terms: Carcinoid Tumor; Malignant Carcinoid Syndrome; Syndrome; Serotonin Syndrome
Intervention: Telotristat etiprate; Octreotide LAR Depot; Placebo
Intervention description: Telotristat etiprate capsules; orally 3 times daily.; A stable-dose octreotide LAR depot therapy; administered subcutaneously once per month.; Placebo-matching telotristat etiprate capsules; orally 3 times daily.
Intervention MeSH terms: Octreotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and tolerability of telotristat etiprate
      (LX1606) versus a placebo control in participants with symptomatic carcinoid syndrome not
      managed by stable-dose long-acting octreotide therapy. Following determination of the
      maximally tolerated or effective dose, cohort expansion will occur to confirm effect on
      symptoms and safety profile.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females, aged 18 and older

          -  Biopsy-proven metastatic carcinoid tumor of the gastrointestinal (GI) tract with
             disease extent confirmed by computed tomography (CT), magnetic resonance imaging
             (MRI), or radionuclide imaging

          -  Symptoms not managed by stable-dose long-acting octreotide therapy (≥4 bowel movements
             per day)

          -  Ability to provide written informed consent

        Exclusion Criteria:

          -  ≥12 high volume, watery bowel movements per day associated with a clinical syndrome of
             volume contraction, dehydration, or hypotension compatible with a "pancreatic
             cholera"-type clinical syndrome

          -  Sponsor-unacceptable clinical laboratory values for hematology and liver function
             tests at screening

          -  Karnofsky status ≤70% - unable to care for self

          -  Surgery within 60 days prior to screening

          -  A history of short bowel syndrome

          -  Life expectancy <12 months

          -  History of substance or alcohol abuse within 2 years prior to screening

          -  Previous exposure to a tryptophan hydroxylase (TPH) inhibitor

          -  Administration of any investigational drug within 30 days of screening or any
             therapeutic protein or antibody within 90 days of screening
Study to Test Sensitivity and Specificity of Passive Wave Pressure Device in Determining Ischemic Stroke
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Ischemia
Intervention: Nautilus NeuroWaveTM System
Intervention description: Non-invasive device designed to detect pressure signals from the skull to aid in the diagnosis of ischemic stroke.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Ischemic Stroke

Summary:

      That the Jan Medical Nautilus NeuroWaveTM system provides significantly higher sensitivity to
      hyper acute ischemic stroke than does CT.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Symptoms consistent with stroke with known onset < 12 hours prior to enrollment and
             planned recording with the Nautilus NeuroWave System

          -  Suspected pathology of following vessels: internal carotid artery, ACA, MCA, PCA,
             basilar or other anterior or posterior cerebral vessels or normal anatomy

          -  Subject is planned to undergo standard stroke triage imaging protocol

          -  Able to understand and provide signed informed consent, or have a Legally Authorized
             Representative willing to provide informed consent on subject's behalf

        Exclusion Criteria:

          -  Known to meet hospital criteria for brain death

          -  Not a candidate for CT, MRI

          -  unknown time of stroke symptom onset.

          -  Psychologically unstable and not able to cooperate

          -  Not suitable for participation in this study in the opinion of the Investigator
HuMax-CD20 in B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients Failing Fludarabine and Alemtuzumab
Condition: Leukaemia, Lymphocytic, Chronic
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: ofatumumab
Intervention description: Intravenous infusion
Intervention MeSH terms: Ofatumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 223.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether HuMax-CD20 (ofatumumab) is effective in the
      treatment of patients failing both fludarabine and alemtuzumab.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Tumor cell phenotype consistent with B-CLL

          2. Patients with active B-CLL and with an indication for treatment

          3. Failing at least one fludarabine-containing treatment regimen

          4. Failing at least one alemtuzumab-containing treatment regimen

          5. ECOG Performance Status of 0, 1, or 2

          6. Life expectancy of at least 4 months

        Exclusion Criteria:

          1. Previous treatment with alemtuzumab within 6 weeks prior to Visit 2

          2. Previous autologous stem cell transplantation within 6 months prior to Visit 2

          3. Allogeneic stem cell transplantation

          4. Radioimmunotherapy
Custodiol-HTK (Histidine-tryptophan-ketoglutarate) Solution as a Cardioplegic Agent
Condition: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Valvular Heart Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Heart Valve Diseases; Ischemia
Intervention: Custodiol HTK; Cold Blood Cardioplegia
Intervention description: After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 10°C.; After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered in an antegrade/retrograde fashion throughout the remainder of the case. The cardioplegic solution was delivered at a temperature of 4°C - 8°C.
Intervention MeSH terms: Tryptophan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Physiological Effects of Drugs; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Mannitol; Cardiac Surgery; Cardioplegic Solutions; HTK solution; Myocardial protection; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases

Summary:

      The purpose of the study is to demonstrate that Custodiol-HTK is not inferior to cold
      cardioplegic solution in patients undergoing cardiovascular surgery requiring cardioplegic
      arrest.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing scheduled cardiac surgery requiring cardioplegic arrest with
             expected cross clamp time>45 minutes

          -  Patients age 18 and older

        Exclusion Criteria:

          -  Pregnant women*

          -  Urgent or emergent cases

          -  Repeat cardiovascular surgical procedures

          -  Patients on dialysis

          -  Any known allergies to components of either cardioplegia solution *All women of child
             bearing potential must have a negative serum or urine pregnancy test.
A Study of Avastin (Bevacizumab) in Combination With Gemcitabine With or Without Cisplatin in First-Line Treatment of Elderly Patients With Non-Small Cell Lung Cancer
Condition: Non-Squamous Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: bevacizumab [Avastin]; cisplatin; gemcitabine; gemcitabine
Intervention description: 7.5mg/kg iv on day 1 of each 3 week cycle; 60mg/m2 on day 1 of each 3 week cycle; 1200mg/m2 on days 1-8 of each 3 week cycle; 1000mg/m2 on days 1-8 of each 3 week cycle
Intervention MeSH terms: Bevacizumab; Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 86.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No

Summary:

      This 2 arm study will evaluate the efficacy and safety of Avastin + gemcitabine, and Avastin
      + gemcitabine + attenuated doses of cisplatin, as first line treatment in elderly patients
      with non-squamous non-small cell lung cancer. Patients will be randomised to receive either
      Avastin 7.5mg/kg iv on day 1 + gemcitabine 1200mg/m2 on days 1-8 of each 3 week cycle, or
      Avastin 7.5mg/kg iv on day 1 + cisplatin 60mg/m2 on day 1 + gemcitabine 1000mg/m2 on days 1-8
      of each 3 week cycle. After 6 cycles of combination therapy, all patients will continue to
      receive Avastin monotherapy. The anticipated time on study treatment is until disease
      progression, and the target sample size is <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=70 years of age;

          -  inoperable, locally advanced, metastatic non-squamous non-small cell lung cancer;

          -  >=1 measurable lesion;

          -  ECOG performance status 0-1.

        Exclusion Criteria:

          -  neoadjuvant/adjuvant chemotherapy within 6 months prior to enrollment;

          -  radical radiotherapy with curative intent within 28 days prior to enrollment;

          -  history of >=grade 2 hemoptysis in 3 months prior to enrollment;

          -  evidence of CNS metastases;

          -  current or recent (within 10 days of first dose of Avastin)use of aspirin (>325
             mg/day)or full dose anticoagulants or thrombolytic agents for therapeutic purposes.
Tofacitinib Ointment For Atopic Dermatitis (Atopic Eczema)
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Tofacitinib ointment 20mg/g; Placebo ointment (Vehicle)
Intervention description: Tofacitinib ointment 20mg/g twice daily (BID) for 4 weeks; Placebo ointment (vehicle) twice daily (BID) for 4 weeks
Intervention MeSH terms: Tofacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Atopic Dermatitis; Atopic Eczema; Eczema; topical treatment; skin diseases; tofacitinib; CP-690; 550; Janus Kinase inhibitor

Summary:

      The study is being conducted to evaluate the efficacy, safety and tolerability of 2%
      tofacitinib ointment (20 mg/g) BID (twice daily) in subjects with mild to moderate atopic
      dermatitis compared to placebo (vehicle) BID for 4 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a clinical diagnosis of atopic dermatitis (also known as atopic eczema) for at
             least 6 months prior to Day 1 that has been clinically stable for at least 1 month
             prior to Day 1 and is confirmed to be atopic dermatitis according to the criteria of
             Hanifin and Rajka.

          -  Have a PGA score of 2 (mild) or 3 (moderate) at Day 1.

          -  Have atopic dermatitis on the head (including face, but excluding hair bearing scalp),
             neck, trunk (excluding groin and genitals), or limbs including palms and soles
             covering at least 2% of total body surface area (BSA) and up to and including 20% of
             total BSA at Day 1. At least 2% of the total BSA will need to be on the head
             (including face, but excluding hair bearing scalp), neck, trunk (excluding groin and
             genitals), or limbs (excluding palms and soles).

        Exclusion Criteria:

          -  Evidence of certain skin conditions/infections at baseline

          -  Currently have atopic dermatitis on groin, genitals, palm or soles

          -  Have certain laboratory abnormalities at baseline

          -  Females who are pregnant, breastfeeding, or are of childbearing potential not using
             highly effective contraception
Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: alpelisib; buparlisib; Placebo
Intervention description: BYL719 + Letrozole; BKM120 + Letrozole; Placebo (of BYL719 or BKM120) + Letrozole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 340.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: BYL719; alpelisib; Breast Cancer; BKM120; buparlisib; Pathological Complete Response; neoadjuvant; hormone receptor-positive; HER2 negative; Objective Response Rate

Summary:

      The purpose of the study was to determine whether treatment with a PI3K inhibitor plus
      letrozole led to an increase in pathologic clinical response and Objective Response Rate
      compared to treatment with placebo plus letrozole in patients with Breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient is an adult, female ≥ 18 years old at the time of informed consent

          2. Patient has a histologically and/or cytologically confirmed diagnosis of breast cancer

          3. Patient is postmenopausal.

          4. Patient has T1c-T3, any N, M0, operable breast cancer

          5. Patients must have measurable disease

          6. Patient has diagnostic biopsy available for the analysis of PIK3CA mutation and Ki67
             level.

          7. Patient has estrogen-receptor and/or progesterone positive breast cancer as per local
             laboratory testing

          8. Patient has HER2 negative breast cancer defined as a negative in situ hybridization
             test or an IHC status of 0 or 1+ as per local laboratory testing

        Exclusion Criteria:

          1. Patient has locally recurrent or metastatic disease

          2. Patient has received any systemic therapy (e.g. chemotherapy, targeted therapy,
             immunotherapy) or radiotherapy for current breast cancer disease before randomization.

          3. Patient with type 1 diabetes mellitus or not adequately controlled type 2 diabetes
             mellitus

          4. History of acute pancreatitis within 1 year of study entry

          5. Uncontrolled hypertension
Effect of Dutasteride on Androgen-Response Gene Expression in Patients With Advanced Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Dutasteride; Placebo
Intervention description: 0.5 mg capsule given orally on daily basis; Identical placebo
Intervention MeSH terms: Dutasteride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 20.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if the drug dutasteride increases expression of
      genes that slow the growth of prostate cancer during treatment with intermittent androgen
      ablation therapy (hormone therapy).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven prostate cancer

          -  Patients are hormone-naive

          -  Patients either to begin androgen ablation therapy with luteinizing hormone-releasing
             hormone (LHRH) agonist or already receiving therapy with LHRH agonist

          -  Advanced prostate cancer with either positive pelvic nodes or bone/visceral metastasis

          -  Must have an intact prostate (no previous surgery or XRT)

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Recovery from any major infection or surgical procedure

          -  Signed informed consent

        Exclusion Criteria:

          -  Known intolerance or allergy to dutasteride

          -  Concomitant chemotherapy, biologic therapy, or XRT to prostate

          -  Bilateral orchiectomy

          -  Prior malignancy within 5 years of registration