bioihbjkbjnl/mcl2 huggingface dataset:
Fludarabine, Cyclophosphamide, and Rituximab - High Dose Frontline
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Fludarabine Phosphate; Cyclophosphamide; Rituximab
Intervention description: 25 mg/m^2 by vein over 5-30 minutes daily for 3 days (days 2-4); 250 mg/m^2 by vein over 60 minutes daily for 3 days (days 2-4); 375 mg/m^2 by vein for dose 1 (given 1 day prior to chemotherapy) and then 500 mg/m^2 on days 2-3
Intervention MeSH terms: Cyclophosphamide; Rituximab; Fludarabine; Fludarabine phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Chronic Lymphocytic Leukemia; CLL; Leukemia; Fludarabine phosphate; Cyclophosphamide; Rituximab; FCR; Cytoxan®; Neosar®; Rituxan®

Summary:

      Primary Objective:

        -  To evaluate the efficacy (combined morphologic and flow remissions) of a combination of
           fludarabine, cyclophosphamide and multiple dose rituximab as frontline therapy for CLL.

      Secondary Objective:

        -  To evaluate remission duration and survival.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 16 years or older

          2. Untreated CLL with indication for therapy or minimally treated (e.g. less than 1 month
             of steroids or chemotherapy) are eligible

          3. Performance status of 3 or better (Appendix A)

          4. Adequate renal and hepatic function (creatinine <2 mg%, bilirubin <2mg%). Patient with
             renal or liver dysfunction due to organ infiltration by lymphocytes may be eligible
             after discussion with the study chairman but upper limits for creatinine even under
             these circumstances would be creatinine < 3 mg% and bilirubin < 6 mg%. Patients with
             Gilbert's Syndrome may be entered on study with bilirubin 2-7 mg%..

          5. A signed informed consent in keeping with policies of the hospital

        Exclusion Criteria:

        1) None
Role of Exenatide in Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Exenatide; Insulin
Intervention description: In each intervention arm the participant receives a different dose (1.25 or 2.5 mcg) of exenatide.; Each subject received a baseline study with insulin alone
Intervention MeSH terms: Exenatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 11.0
Sex: All
Minimum age: 12 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Hypoglycemia; Hyperglycemia

Summary:

      The purpose of this study is to see if giving exenatide and insulin before a meal would lower
      blood sugars after the meal. This study may help in developing new treatments to help control
      high blood sugars after meals. This may help improve overall blood sugar control and prevent
      the long-term effects of diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

        ***Subjects must be patients of the Texas Children's Hospital Diabetes Care Center***.

        All of the following criteria must be met:

          1. Between 12-21 years of age at the time of enrollment.

          2. Have been diagnosed with Type 1 diabetes for at least 1 year and in good control
             (HbA1C less than 8.5%).

          3. Subjects must be otherwise healthy except for the Type 1 Diabetes and treated
             hypothyroidism.

          4. Menstruating women must have a negative pregnancy test.

          5. Hemoglobin equal to or greater than 12 g/dL before each study.

          6. Weight greater than 44 kg.

          7. Tanner stage greater than 3

        Exclusion Criteria:

          1. Any chronic disease: leukemia, asthma, inflammatory bowel disease, cystic fibrosis,
             juvenile rheumatoid arthritis etc or on treatment that might directly or indirectly
             affect glucose homeostasis, except for diabetes and hypothyroidism; stable on
             medications.

          2. Lack of a supportive family environment as detected by the clinicians and/or social
             workers.

          3. Positive pregnancy test in menstruating young women.

          4. BMI greater than 90th percentile for age or less than 10th percentile for age.

          5. Lactating and nursing mothers.
Explorative Study of Degarelix for Treatment of Benign Prostatic Hyperplasia.
Condition: BPH
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Intervention: Degarelix; Degarelix; Degarelix; Degarelix
Intervention description: Two doses of 16 mg each administered as two administrations (separated by 14 days) will be evaluated for 42 days.; One dose of 32 mg administered as a single administration will be evaluated for 42 days.; Two doses of 32 mg each administered as two administrations (separated by 14 days) will be evaluated for 42 days.; One dose of 64 mg administered as a single administration will be evaluated for 42 days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: Male
Minimum age: 55 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Benign Prostate Hyperplasia; BPH; PK/PD; GnRH antagonist

Summary:

      This exploratory study will be conducted open label in a single investigational clinical
      unit. Altogether 52 patients with benign prostate hyperplasia (BPH) will be randomly assigned
      to receive 4 different treatments with degarelix.
    

Eligibility criteria:

        Inclusion Criteria:

        Each patient must comply with all of the following inclusion criteria to be allowed to be
        randomised into the study:

          1. Man, 55 to 75 years of age.

          2. Clinical diagnose of BPH with a prostate volume more than 30 mL, a maximal uroflow of
             12 mL/sec or less and an international prostate sympton score (IPSS) of 13 or more at
             screening.

          3. A prostate specific antigen (PSA) value less than 10 ng/mL and no clinical evidence of
             adenocarcinoma of the prostate at screening. If a biopsy of the prostate is performed,
             a period of 6 weeks should be allowed after the biopsy before the patient is enrolled
             into the study.

          4. Has a baseline testosterone level above 3 ng/mL at screening.

        Exclusion Criteria:

        Any patient meeting one or more of the following exclusion criteria will not be included
        into the study:

          1. Previous surgery of the prostate.

          2. Previous treatment with GnRH agonists or GnRH antagonists.

          3. Treatment with 5-alpha reductase inhibitors, e.g., finasteride (Prosca®)or dutasteride
             (Avodart®) within the past 12 months before the study.

          4. Treatment with alpha-adrenergic antagonists, e.g., terazosin, doxazosin, tamsulosin,
             alfuzosin within 2 weeks prior to Screening part II (or Part I, if IPSS is performed
             at Screening part I).

          5. Treatment with any drug modifying the testosterone level or function within 12 weeks
             before Screening visit part II (or Part I, if IPSS is performed at Screening part I).
Repeated-Dose Oral N-acetylcysteine for the Treatment of Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: N-acetylcysteine capsule
Intervention description: N-acetylcysteine capsule
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The investigators are interested in evaluating the use of oral N-acetylcysteine (NAC) as
      therapy for Parkinson's Disease (PD) and measuring changes in brain and blood chemistry.
    

Eligibility criteria:

        Inclusion Criteria:

          1. All participants must be 18 years or older

          2. All enrollees must understand and cooperate with requirements of the study in the
             opinion of the investigators and must be able to provide written informed consent

          3. Individuals with medically stable Parkinson's disease (in the opinion of the
             investigator)

          4. All participants must not have taken antioxidants NAC, glutathione, coenzyme Q-10,
             vitamin C, or vitamin E for 3 weeks prior to the study

          5. Absence of dementia in all subjects

        Exclusion Criteria:

          1. Inability to undergo MRI scanning without sedation and other MRI counterindications,
             such as metal in the body (see section 7.3)

          2. Medically unstable conditions as determined by the investigators

          3. Pregnant or lactating or those women of child-bearing age that are not using
             acceptable forms of contraception

          4. Diagnosis of asthma that is presently being treated with any medication, or past
             history of asthma/bronchospasm resulting in an emergency room visit, hospitalization
             or treatment

          5. Unable to adhere to study protocol for whatever reason
A Study to Evaluate Efficacy and Safety of Epoetin Beta (NeoRecormon®) in Anemic Participants With Breast Cancer Undergoing Chemotherapy
Condition: Anemia
Intervention: Epoetin Beta
Intervention description: All participants will receive epoetin beta at a dose of 30000 International Units (IU) as SC injection once every week for a total of 12 weeks. Adjustments in the dose will be implemented based on the participant's blood hemoglobin levels.
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of subcutaneous (SC) epoetin beta in anemic
      participants with breast cancer undergoing chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult female participants with histological diagnosis of breast cancer

          -  Any type of chemotherapy planned for greater than or equal to (>/=) 9 weeks

          -  Hemoglobin level less than (<) 11 grams per deciliter (g/dL)

          -  Participants able to receive iron supplement, if necessary

        Exclusion Criteria:

          -  Known or suspected contraindications to epoetin beta

          -  Pregnancy or lactation period

          -  Diagnosis of anemia only due to iron-deficiency

          -  Diagnosis of thalasemic syndromes

          -  Epilepsy and/or cerebral metastasis

          -  Blood transfusion or treatment with any erythropoietic factor within 4 weeks before
             study start
Topical CP-690,550 For Chronic Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: CP-690,550; CP-690,550; CP-690,550; CP-690,550; CP-690,550; CP-690,550; Placebo Vehicle; Placebo Vehicle
Intervention description: Topical treatment once daily for 28 days; Topical treatment once daily for 28 days; Topical treatment once daily for 28 days; Topical treatment twice daily for 28 days; Topical treatment twice daily for 28 days; Topical treatment twice daily for 28 days; Topical treatment once daily for 28 days; Topical treatment twice daily for 28 days
Intervention MeSH terms: Tofacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: chronic plaque psoriasis; topical treatment

Summary:

      Study will test effectiveness of an experimental drug applied once or twice daily to two
      psoriasis plaques. Requires 1 clinic visit each week for 5 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Having chronic plaque psoriasis for at least 6 months

          -  Able to withdraw all prior psoriasis treatments

          -  Must agree to avoid prolonged exposure to the sun and avoid use of tanning booths or
             other ultraviolet light sources during the study

        Exclusion Criteria:

          -  Evidence of active, latent, or inadequately treated infection with Mycobacterium
             tuberculosis

          -  Pregnant or lactating women

          -  Unwilling to use appropriate contraceptive methods
Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Patients With Hemodialysis (HD)
Condition: Secondary Hyperparathyroidism; Hemodialysis
MeSH terms: Neoplasm Metastasis; Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: Paricalcitol
Intervention description: Intravenous (IV) paricalcitol, 3 times weekly, immediately before completion of hemodialysis.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 107.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Secondary hyperparathyroidism; Hemodialysis; paricalcitol

Summary:

      The purpose of this study is to evaluate the long-term safety of paricalcitol injection.
      Subjects will administer clinical supplies 3 times a week, 40 weeks at dialysis session in
      dose-titration manner, following 12 weeks of treatment in the dose-response study, M10-309
      (NCT00667576).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who completed 12 weeks of Study M10-309 (NCT00667576).

        Exclusion Criteria:

          -  Patients taking drugs that affect intact parathyroid hormone (iPTH), calcium, or bone
             metabolism.

          -  Patients with progressive malignancy or clinically significant hepatic disease.

          -  Patients who developed severe cerebrovascular/cardiovascular disease during the
             dose-response portion of the study (i.e., during M10-309, NCT00667576).

          -  Patients with uncontrolled diabetes during the dose-response portion of the study
             (i.e., during M10-309, NCT00667576).
Efficacy and Safety of Liraglutide in Subjects With Type 1 Diabetes Undergoing Islet Cell Transplantation
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: liraglutide; placebo
Intervention description: Dose escalation of liraglutide up to 1.2 to 1.8 mg before islet cell transplant until the planned number of transplanted subjects is complete or subject is transplanted. After islet cell transplant, subjects continue to receive the reached liraglutide dose for 52 weeks. Injected subcutaneously(under the skin) once daily.; Dose escalation escalation of liraglutide up to 1.2 to 1.8 mg before islet cell transplant until the planned number of transplanted subjects is complete or subject is transplanted. After islet cell transplant, subjects continue to receive the reached liraglutide placebo dose for 52 weeks. Injected subcutaneously (under the skin) once daily.
Intervention MeSH terms: Liraglutide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe and North America. The aim of this trial is to investigate
      if liraglutide treatment can increase the proportion of insulin-independent subjects one year
      after islet cell transplantation who required only one (single-donor) islet cell transplant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 1 diabetes mellitus for at least 5 years

          -  Candidate for islet cell transplantation based upon local accepted practice and
             guidelines

          -  Reduced awareness of hypoglycaemia

        Exclusion Criteria:

          -  Treatment with any anti-diabetic medication other than insulin including insulin pump
             within 4 weeks of trial start

          -  Any previous organ transplantation

          -  A history of acute idiopathic or chronic pancreatitis

          -  Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial
             medullary thyroid carcinoma (FMTC)
Pharmacokinetics of Advantage Arrest in Children
Condition: Dental Caries
MeSH terms: Dental Caries
Intervention: Silver Diamine Fluoride
Intervention description: 38% aqueous silver diamine fluoride [Ag(NH3)]2F, CAS RN 33040-28-7
Intervention MeSH terms: Fluorides
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open label exposure--response study
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 3 Years
Maximum age: 13 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: child; pharmacokinetics; silver diamine fluoride

Summary:

      The purpose of this study is to characterize basic PK parameters (Cmax, t1/2, AUC) in healthy
      children to contribute to evidence for the safety of Advantage Arrest, consistent with
      Guidance for Industry--Exposure--Response Relationships (April 2003).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy.

          -  At least one carious lesion.

        Exclusion Criteria:

          -  Oral mucositis

          -  Any ulcerative lesions

          -  Hypersensitivity to silver

          -  Hypersensitivity to fluoride.

          -  SDF treatment within 3 months.
Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone Disorder
Condition: Secondary Hyperparathyroidism
MeSH terms: Neoplasm Metastasis; Bone Diseases; Chronic Kidney Disease-Mineral and Bone Disorder; Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: Etelcalcetide
Intervention description: Administered 3 times a week by bolus injection into the venous line of the dialysis circuit after the end of hemodialysis.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Clinical Trial, Phase 2; Renal Dialysis; Secondary Hyperparathyroidism; Chronic kidney disease-mineral and bone disorder; Parathyroid hormone

Summary:

      The purpose of this study is to evaluate the effect of thrice weekly intravenous (IV)
      administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in
      hemodialysis patients with chronic kidney disease-mineral and bone disorder (CKD-MBD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects provides written informed consent

          -  Screening intact PTH (iPTH) ≥ 350 pg/mL and corrected calcium ≥ 8.5 mg/dL

          -  Hemoglobin ≥ 8.5 g/dL

          -  Serum transaminases (alanine transaminase [ALT], aspartate transaminase [AST]) less
             than 2.5 times the upper limit of normal

          -  Adequate hemodialysis three times per week

        Exclusion Criteria:

          -  History or symptomatic ventricular dysrhythmias

          -  History of angina pectoris or congestive heart failure

          -  History of myocardial infarction, coronary angioplasty, or coronary artery bypass
             grafting within the past 6 months

          -  History of or treatment for seizure disorder within the last 12 months

          -  Postdialysis systolic blood pressure > 180 mmHg or diastolic blood pressure > 90 mmHg

          -  Serum magnesium below the lower limit of normal at screening
A Rollover Study For Subjects Discontinuing From UK-453,061 Studies For The Treatment Of HIV-1
Condition: HIV-1
Intervention: No drug will be administered
Intervention description: No drug will be administered.
Phase: Phase 2
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV-1; Rollover; Safety.; HIV Infections; treatment experienced

Summary:

      The purpose of the protocol is to assess long-term safety and tolerability of subjects who
      discontinue for any reason from UK-453,061 qualifying studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previous participation in a qualifying study.

          -  Male or female at least 18 years of age available for a follow-up period of at least
             96 weeks.

        Exclusion Criteria:

          -  Concurrent treatment in another clinical trial.

          -  Unwilling or unable to be followed for 12 months
Treating Tobacco Dependence in Inpatient Psychiatry - 1
Condition: Tobacco Use Cessation; Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Intervention: stage-tailored intervention
Intervention description: This intervention consists of nicotine patch therapy during hospitalization; a stage-based self-help manual; an individualized, expert-system, feedback report at intake, 3 months and 6 months post-hospitalization with carbon copies sent to participants' outpatient clinicians; and an individual 30-min smoking cessation counseling sessions during hospitalization. Additionally, up to 10 weeks of nicotine patch is provided to intervention participants intending to stay quit following hospital discharge.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 224.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: tobacco

Summary:

      The purpose of this study is to test in a randomized clinical trial a series of hypotheses
      concerning the efficacy of an extended expert-system intervention plus nicotine replacement
      therapy (NRT) for treating tobacco dependence among patients hospitalized on a smoke-free
      psychiatric unit.
    

Eligibility criteria:

        Inclusion Criteria: Men and women over 18 years of age hospitalized on an inpatient
        psychiatric unit who report smoking at least 5 cigarettes per day; smoking at least 100
        cigarettes in one's lifetime, residing in the San Francisco Bay Area with no plan to
        relocate outside of the area in the next 18 months, and access to a telephone for
        scheduling follow up assessments.

        Exclusion Criteria: Dementia or other brain injury precluding ability to participate;
        non-English speaking; severe agitation, psychosis, or hostility; and medical
        contraindications to nicotine replacement therapy (NRT). Recruitment of acutely psychotic,
        manic, or hostile patients will be delayed until there is significant reduction of these
        symptoms. Medical contraindications are: myocardial infarction in the preceding 3 months,
        unstable angina pectoris, liver or kidney disease, current pregnancy or breast feeding,
        allergies to adhesives, or other medical conditions that the medical team deems
        incompatible with NRT use.