bioihbjkbjnl/mcl2 huggingface dataset:
Losartan to Reduce Inflammation and Fibrosis Endpoints in HIV Trial
Condition: Inflammation; Fibrosis
MeSH terms: Fibrosis; Inflammation
Intervention: Losartan 100mg daily; Matching placebo
Intervention MeSH terms: Losartan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 108.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the potential effectiveness of losartan (100mg
      daily) for reducing inflammation and improving immune recovery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV infection (verified by previous positive antibody or detectable HIV RNA level)

          -  Age > 50 years

          -  Receiving continuous ART for >= 2 years (regimen changes > 6 months prior to
             enrollment are allowed)

          -  HIV RNA level < 200 copies/mL for >= 1 year (1 measure >= 200 allowed if also < 1000
             and preceded and followed by values < 200 copies/mL)

          -  Blood CD4+ T-cell count < 600 cells/mm cubed

          -  Systolic blood pressure > 120 mmHg (mean value if >= 2 measures obtained)

          -  Estimated glomerular filtration rate (GFR )> 30 mL/min/1.73 m squared

          -  Do not anticipate starting or stopping statin or aspirin therapy during the study

        Exclusion Criteria:

          -  Pregnancy or breastfeeding

          -  A contra-indication to taking an angiotensin receptor blocker (ARB) (e.g., cirrhosis,
             prior angioedema with angiotensin-converting enzyme inhibitor (ACE-I), or use of drug
             with potential drug-interaction [e.g., rifaximin])

          -  A clinical indication for ARB or ACE-I therapy (e.g., cardiovascular disease (CVD),
             stroke, or diabetes mellitus (DM))

          -  Current treatment with ARB or medication with overlapping mechanism (e.g., ACE-I or
             aldosterone antagonist)

          -  Current treatment with immunomodulatory drugs within the past 6 months

          -  Current hepatitis treatments (e.g., interferon, ribavirin) within the past 6 months

          -  Serum potassium > 5.0 millimoles per liter (mmol/L) within 3 months of entry

          -  Invasive cancer in the prior year or receiving cancer treatment (not including
             carcinoma-in-situ or basal cell cancer of the skin)

          -  Cirrhosis or end-stage liver disease

          -  Rheumatologic or chronic inflammatory disease (e.g., systematic lupus erythematous,
             psoriasis, rheumatoid arthritis, vasculitis, sarcoidosis, Crohn's disease)
Cord Blood Transplantation for Patients With Cancer
Condition: Hematological Disease
MeSH terms: Hematologic Diseases
Intervention: Melphalan; Fludarabine; Antithymocyte Globulin (ATG); Busulfan; Total Body Irradiation (TBI)
Intervention description: Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.; Fludarabine is given through the vein daily for 5 days.; ATG is given every other day for 4 days.; Busulfan is given daily for 4 days.; TBI is given twice on the last day.
Intervention MeSH terms: Fludarabine; Fludarabine phosphate; Melphalan; Busulfan; Antilymphocyte Serum
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to assess the rate of engraftment with combined
      haploidentical-cord blood transplantation in patients with pre-existing donor specific
      antibodies and in those with active disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Relapsed or refractory acute leukemia (myeloid or lymphoid)

          -  Acute leukemia in first remission at high-risk for recurrence

          -  Chronic myelogenous leukemia in accelerated phase or blast-crisis

          -  Chronic myelogenous leukemia in chronic phase

          -  Recurrent or refractory malignant lymphoma or Hodgkin lymphoma

          -  Chronic lymphocytic leukemia, relapsed or with poor prognostic features

          -  Multiple myeloma

          -  Myelodysplastic syndrome

          -  Chronic myeloproliferative disease

          -  Hemoglobinopathies

          -  Aplastic anemia

        Exclusion Criteria:

          -  Zubrod performance status > 2

          -  Life expectancy is severely limited by concomitant illness

          -  Patients with severely decreased LVEF or impaired pulmonary function tests

          -  Estimated Creatinine Clearance <50 ml/min

          -  Serum bilirubin> 2.0 mg/dl or SGPT >3 x upper limit of normal

          -  Evidence of chronic active hepatitis or cirrhosis

          -  HIV-positive

          -  Patient is pregnant

          -  Patient or guardian not able to sign informed consent
Dose-Range Finding Study for MK0893 (0893-008)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: MK0893; Metformin; Placebo to MK0893; Placebo to Metformin
Intervention description: MK0893 taken orally once daily; 20 mg and 40 mg tablets used in combination according to dose.; Metformin HCL 500 mg tablet twice daily titrating up to 1000 mg twice daily over 3 weeks.; Dose-matched placebo tablets to MK0893; taken orally once daily.; Dose-matched placebo tablets to metformin (500 mg); taken orally twice daily.
Intervention MeSH terms: Metformin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 342.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      A study to compare MK0893 to metformin or placebo for patients with Type 2 diabetes (Diabetes
      Mellitus).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have Type 2 Diabetes Mellitus, with suboptimal glucose control, while
             either not on AHA (antihyperglycemic agent) therapy or on monotherapy or on low-dose
             combination therapy

        Exclusion Criteria:

          -  Patients have a history of Type 1 Diabetes Mellitus

          -  Patients taking insulin or thiazolidinedione (TZD, a peroxisome proliferator-activated
             receptor [PPAR]-gamma agonist)

          -  Patients who have a contraindication to metformin
Role of the Orexin Receptor System in Stress, Sleep and Cocaine Use
Condition: Cocaine Use Disorder; Anxiety
Intervention: suvorexant; Placebo (for suvorexant)
Intervention description: Subjects will receive suvorexant capsules (10 mg week 1, 20 mg week 2), once daily at 10 PM.; Subjects will receive placebo capsules once daily at 10 PM.
Intervention MeSH terms: Suvorexant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 19 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: cocaine; sleep; anxiety; craving; addiction; orexin; cue reactivity; suvorexant; Belsomra

Summary:

      The purpose of this study is to determine the effectiveness of a medication called suvorexant
      in reducing anxiety, improving sleep, and reducing cocaine cravings or cocaine use.
    

Eligibility criteria:

        Inclusion Criteria:

          -  meet current DSM-5 criteria for cocaine use disorder (CUD) of at least moderate
             severity (≥4 symptoms)

        Exclusion Criteria:

          -  current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine,
             marijuana, or nicotine

          -  have a DSM-IV axis I psychiatric disorder or neurological disease or disorder
             requiring ongoing treatment and/or making study participation unsafe

          -  significant current suicidal or homicidal ideation

          -  medical conditions contraindicating administration of suvorexant (e.g., severe
             pulmonary disease, severe cardiovascular disease or clinically abnormal EEG, severe
             liver or kidney disease, seizure disorder, or sleep disorder - particularly
             narcolepsy)

          -  taking medications known to have significant drug interactions with the study
             medication(s) (e.g., MAO inhibitors, anticonvulsants, haloperidol, phenothiazines,
             anesthetics, and all sedatives)

          -  currently or recently (last 3 months) treated for substance use [other than cocaine or
             nicotine] or another psychiatric condition

          -  conditions of probation or parole requiring reports of drug use to officers of the
             court; (8) impending incarceration

          -  pregnant or nursing for female patients

          -  inability to read, write, or speak English [required for lab tasks and psychometric
             scales]

          -  unwillingness to sign a written informed consent form

          -  subjects with alcohol use disorders or are drinking > 7 alcoholic drinks per week. All
             subjects who are excluded will be given referral information to other local treatment
             programs.
Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Bexarotene
Intervention description: Bexarotene given orally at a dose of 300mg/m2 until disease progression or unacceptable toxicities experienced by patient
Intervention MeSH terms: Bexarotene
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute Myeloid Leukemia; AML; Bexarotene

Summary:

      The purpose of this study is to evaluate the activity of bexarotene, a retinoic acid class
      drug, in patients with Acute Myeloid Leukemia (AML) that has returned after or is resistant
      to standard chemotherapy or are otherwise not eligible for conventional chemotherapy.
      Retinoic acids are a class of drugs related to Vitamin A, and have a wide range of effects
      within normal and malignant cells that affect cell growth and cell death.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >= 18 years

          -  Confirmed diagnosis of AML as proven by bone marrow biopsy

          -  Must have received prior induction therapy with conventional chemotherapy and/or
             Mylotarg or otherwise not eligible for conventional chemotherapy

          -  ECOG performance status of 0-2

          -  Recovered from toxicities of prior chemotherapy

        Exclusion Criteria:

          -  History of pancreatitis

          -  Active alcohol abuse

          -  Taken bexarotene in the past

          -  WBC > 10,000/uL at time of enrollment

          -  Cytotoxic therapy within the past 14 days other than hydrea, low dose cytarabine or
             low dose Mylotarg

          -  Significant organ disfunction: total bilirubin > 3x ULN, AST or ALT >3 x ULN,
             creatinine > 3 mg/dL, on blood pressure supporting medications or mechanical
             ventilation

          -  Active participant in any other investigational treatment study for AML

          -  Life expectancy of less than 1 month

          -  Use of blood growth factors (G-CSF, GM-CSF, Aranesp, erythropoietin, or Neumega)
             within 1 week prior to treatment initiation

          -  Uncontrolled hyperlipidemia

          -  Known history of HIV

          -  Known active CNS involvement with AML

          -  Women of childbearing potential or active breast feeding
Immunophenotyping of Fresh Stromal Vascular Fraction From Adipose Derived Stem Cells (ADSC) Enriched Fat Grafts
Condition: Breast Reconstruction; Contour Irregularities; Volume Insufficiency
Intervention: centrifuged fat graft; ADSCs enriched fat graft
Intervention description: fat from the abdominal subcutaneous tissue will be taken by vacuum assisted lipectomy and immediately prepared to be grafted in the reconstructed breast that presents contour irregularities and/or volume insufficiency. No adipose derived stem cells will enrich the fat grafts in this group.; fat from the abdominal subcutaneous tissue will be taken by suction assisted lipectomy and stromal vascular fraction will be isolated and immediately added to the fat graft that will be employed to improve contour irregularities and volume insufficiency of reconstructed breasts.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 20.0
Sex: Female
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: adipocytes; cell transplantations; mesenchymal stem cell; immunophenotyping; adipose tissue; breast reconstruction; mammaplasty; magnetic resonance imaging; fat necrosis

Summary:

      The purpose of this study is to investigate if there is a relationship between the take of
      fat grafts with and without ADSCs and the presence of specific surface markers on the cells
      of the stromal vascular fraction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  contour irregularities and volume insufficiency in reconstructed breasts no matter the
             method of reconstruction employed

          -  local flaps with conditions to receive fat grafts

          -  good health condition

        Exclusion Criteria:

          -  breast cancer patients under chemotherapy

          -  smokers

          -  bad health condition

          -  patients too thin

          -  patients that require a new reconstructive surgery (secondary reconstruction)
Allogeneic Transplantation in Patients With Cutaneous T-Cell Lymphoma
Condition: Lymphoma; Disorder Related to Bone Marrow Transplantation
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous
Intervention: Fludarabine; Melphalan; Allogeneic Transplant; Thymoglobulin
Intervention description: 25 mg/m^2 Given By Vein Daily for 5 Days Prior to Allogeneic Transplant.; 70 mg/m^2 Given By Vein Daily for 2 Days Prior to Allogeneic Transplant.; Allogeneic transplant given by vein after completion of Fludarabine and Melphalan.; 2 mg/kg/day by vein on days -3, -2 and -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow.
Intervention MeSH terms: Fludarabine; Fludarabine phosphate; Melphalan; Thymoglobulin; Antilymphocyte Serum
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Cutaneous T-Cell Lymphoma; CTCL; Allogeneic Transplantation; Lymphoma; Allogeneic peripheral blood progenitor cell; PBPC; Bone Marrow transplantation; Stem Cell Transplant; SCT; Fludarabine; Fludarabine Phosphate; Fludara; Melphalan

Summary:

      The goal of this clinical research study is to see if receiving a transplant of blood stem
      cells (cells that can produce blood) or bone marrow from either a related donor (brother,
      sister or other relative) or an unrelated voluntary donor will help patients with advanced
      cutaneous T-cell lymphoma. The length of time that patients who receive the treatment remain
      free of disease will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with pathologically proven cutaneous T-cell lymphoma (CTCL), disease stage
             IIB to IVB, patients must be in at least a partial response-PR (skin and lymph nodes)
             after receiving other non-allogeneic transplant therapy, age </= 70 years, Zubrod
             performance status 0 or 1, left ventricular ejection fraction >/= 50% or approved for
             transplant by a cardiologist, DLCO >/= 50% predicted or approved for transplant by a
             pulmonologist, serum creatinine </= 1.5 mg/dL, serum bilirubin < 2mg/dL. SGPT < 3 x
             upper limit of normal, and no previous history of allogeneic transplantation.

          2. Donor: HLA-compatible related (HLA-A, -B, -DRB1 matched or with one-antigen mismatch)
             or HLA-compatible unrelated (HLA-A, -B, -C and -DRB1 matched or with one-antigen
             mismatch).

        Exclusion Criteria:

        1) Patients cannot have active central nervous system (CNS) disease.
A Study of Quetiapine and Mirtazapine for the Treatment of Alcohol Dependency
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Intervention: Mirtazapine; Quetiapine fumarate extended release (Quetiapine XR)
Intervention description: mirtazapine (7.5-45mg); Quetiapine fumarate extended release 50-400mg/d
Intervention MeSH terms: Quetiapine Fumarate; Mirtazapine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to test whether taking two medicines (quetiapine and mirtazapine)
      is better for helping people to decrease drinking than taking one medicine alone
      (quetiapine).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18-64

          2. The subject meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition
             (DSM-IV) criteria for alcohol dependence

          3. The subject is seeking treatment for alcohol dependence and desires a reduction or
             cessation of drinking

          4. The subject is able to verbalize understanding of the consent form, able to provide
             written informed consent, and able to verbalize willingness to complete study
             procedures?

          5. If the subject is female and of child bearing potential, she agrees to use an
             acceptable method of birth control.

          6. The subject is able to take oral medication, willing to adhere to the medication
             regimen, and willing to return for regular visits.

          7. The subject is able to understand written and oral instructions in English and able to
             complete the questionnaires required by the protocol.

          8. The subject has a breath alcohol concentration (BAC) equal to 0.000 on s/he signing
             the informed consent document.
Long-Term Dopamine Transporter Imaging and Clinical Assessment of Parkinson's Disease Progression
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: [123I]B-CIT SPECT imaging
Intervention description: To assess [123I]B-CIT SPECT imaging
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 142.0
Sex: All
Minimum age: 22 Years
Healthy volunteers: No
Keywords: parkinson; brain imaging

Summary:

      The purpose of this project is to assess the change in dopamine transporter density in
      Parkinson's disease subjects during a sixty month period including a nine month treatment
      trial of levodopa. Dopamine transporter will be assessed using [123I]ß-CIT SPECT (single
      photon emission computed tomography) imaging, a marker of dopamine terminal integrity and of
      clinical disease state.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prior participation in the study titled Dopamine Transporter Imaging Assessment of
             Parkinson's Disease Progression (DAMD17-99-1-9472) [123I] B-CIT and Spect in Vivo
             Imaging Assessment of Dopamine Transporter Density in Subjects With Early Parkinson's
             Disease Participating in Earlier Vs. Later Levodopa in Parkinson's Disease (ELLDOPA)].

        Exclusion Criteria:

          -  Inability to sign informed consent and participate in all study procedures.

          -  Mini mental status exam < 25.

          -  Pregnancy
Oral Immunotherapy for Childhood Egg Allergy
Condition: Hypersensitivity; Immediate Hypersensitivity; Food Hypersensitivity
MeSH terms: Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate
Intervention: Egg oral immunotherapy; Control Group
Intervention description: Egg white solid powder; Placebo for egg white solid
Intervention MeSH terms: Immunomodulating Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 55.0
Sex: All
Minimum age: 5 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Egg Allergy; Egg Oral Immunotherapy (OIT); Food Allergy

Summary:

      The purpose of this study is to determine if oral immunotherapy (OIT) will desensitize a
      child with an allergy to egg and eventually lead to the development of tolerance to egg.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Convincing clinical history of egg allergy

          -  Age 6 to 18 years, with a serum IgE [UniCAP] to egg > 5 kUA/L OR

          -  Age 5 to 6 years, with a serum IgE [UniCAP] to egg ≥ 12kUA/L

          -  Parent/guardian willing to provide informed consent

          -  Willing to use acceptable forms of contraception

        Exclusion Criteria:

          -  History of severe anaphylaxis to egg. More information on this criterion can be found
             in the protocol.

          -  Known allergy to corn

          -  Chronic disease requiring therapy (e.g., heart disease, diabetes). Participants who
             have asthma, atopic dermatitis, or rhinitis are not excluded.

          -  Participation in any interventional study for the treatment of food allergy in the 6
             months prior to study entry

          -  Participant is on "build-up phase" of immunotherapy and has not reached maintenance
             dosing. Participants tolerating maintenance allergen immunotherapy are not excluded.

          -  Severe asthma, uncontrolled mild or moderate asthma. More information on this
             criterion can be found in the protocol.

          -  Inability to discontinue antihistamines for the initial day of escalation, skin
             testing, and OFC

          -  Omalizumab or other nontraditional forms of oral or sublingual allergen immunotherapy,
             immunomodulator therapy, or biologic therapy in the 12 months prior to study entry.
             Participants who have taken corticosteroids are not excluded.

          -  Investigational drugs 90 days prior to study entry or planned use of an
             investigational drug during the study period

          -  Pregnancy or breastfeeding