bioihbjkbjnl/mcl2 huggingface dataset:
Recombinant Human Prolactin for Lactation Induction
Condition: Lactation
Intervention: Recombinant Human Prolactin; Recombinant human prolactin; Normal Saline
Intervention description: 60 mcg/kg every 12 hours; 60 mcg/kg given every 12 hours or every 24 hours; twice per day
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 11.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Lactation; Breastfeeding; Premature infants; Prolactin; Primary lactation insufficiency

Summary:

      The purpose of the study is to assess the safety and determine the effects of the hormone
      prolactin on lactation (breast milk production).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy women, aged 18-45 years

          -  Lactation insufficiency postpartum

          -  Subjects will be women with children in the neonatal Intensive Care Unit (ICU) who are
             pumping breast milk for their infant's nutritional support and to maintain their milk
             supply.

          -  Subjects will have given birth at a gestational age of at least 24 weeks, and will
             generally be recruited 4-8 weeks postpartum.

        Exclusion Criteria:

          -  Medications known to increase prolactin

          -  Anatomical breast abnormalities

          -  Use of medication contraindicated in breastfeeding mothers

          -  Allergies to mannitol

          -  Current use of hormonal contraception

          -  Previous mammoplasty or breast augmentation, unless they have successfully nursed an
             infant for 3 months in the past without requiring supplemental formula.
Endothelial Facilitation in Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Simvastatin; L-Arginine; Tetrahydrobiopterin
Intervention description: Simvastatin, 40 mg per day orally; L-Arginine, 2 Gm four times per day orally;; Tetrahydrobiopterin 20 mg/kg/day orally
Intervention MeSH terms: Simvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 55 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Early Alzheimer; Mild Cognitive Impairment; Drug treatment; Cerebral blood flow; Endothelial facilitation; Cognitive improvement

Summary:

      Purpose of the study: Patients with mild Alzheimer's Disease will be given three different
      drugs over a 4-month period to try to increase the blood flow to their brains, and improve
      blood vessel and brain function. Each drug can help to open the blood vessels in the brain,
      and together they may be more effective than each drug alone. The hypothesis is that small
      blood vessels secrete substances that maintain the integrity of the brain, and may prevent
      loss of nerve cells leading to Alzheimer's Disease
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have mild Alzheimer's Disease or Mild Cognitive Impairment (MCI);

          -  age between 55-85;

          -  Mini Mental Status Exam (MMSE) between 15-26;

          -  a caregiver who can provide information, and bring patient to the sessions;

          -  no known allergies to any of the medications to be used;

          -  normal renal function; willingness of patient and spouse/responsible caregiver to
             participate.

        Exclusion Criteria:

          -  Significant Psychiatric disorder;

          -  stroke; current use of any of the test medications (e.g., statin, L-Arginine, Kuvan);

          -  phenylketonuria (PKU) ;

          -  elevated serum phenylalanine level (>10 mg/dL);

          -  allergy to any of the medications; current active malignancy;

          -  renal insufficiency (elevated creatinine above 1.3mg/dl);

          -  abnormal liver function (Alanine Aminotransferase (ALT) or Aspartate Transaminase
             (AST) 2x normal);

          -  other serious disease including coronary insufficiency or congestive heart failure,
             carotid stenosis greater than 50%, active peptic ulcer, urinary tract or other active
             infection, cancer (except skin cancer, or 5 years inactive breast or prostate cancer
             )etc.;

          -  pregnancy; or

          -  inability to come to UMass for follow-up. Subjects may continue to take
             anticholinesterase drugs for Alzheimer's Disease (Aricept, Exelon, Razadyne) and/or
             Namenda, if they have been on the drug(s) for at least 3 months. Subjects on levodopa
             and male subjects taking drugs for erectile dysfunction (Viagra, Cialis, Levitra) are
             cautioned regarding hypotension.
LGX818 for Patients With BRAFV600 Mutated Tumors
Condition: Solid Tumor; Hematologic Malignancies
MeSH terms: Hematologic Neoplasms
Intervention: LGX818
Intervention description: LGX818 will be dosed on a flat scale of 300 mg (e.g., 3 x 100 mg capsules) once daily on a continuous dosing cycle. A complete treatment cycle is defined as 28 days. There will be no breaks between dosing cycles.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this signal seeking study is to determine whether treatment with LGX818
      demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic
      malignancies to warrant further study
    

Eligibility criteria:

        Inclusion Criteria

          -  Patient has a confirmed diagnosis of a select solid tumor (except with a primary
             diagnosis of melanoma and colorectal cancer (CRC)) or hematologic malignancies and is
             in need of treatment because of progression or relapse.

          -  Patient's tumor has been evaluated and pre-identified as having a tumor with a
             BRAFV600 mutation at a CLIA certified laboratory.

          -  Patient must have received at least one prior treatment for recurrent, metastatic and
             /or locally advanced disease and for whom no standard therapy options are anticipated
             to result in a durable remission.

          -  Patient must have progressive and measurable disease per RECIST 1.1. or other
             appropriate hematological response criteria.

          -  Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

        Exclusion Criteria:

          -  Patient has received prior treatment with LGX818.

          -  Patients with Central Nerve System (CNS) metastasis or leptomeningeal carcinomatosis.

          -  Patient has received chemotherapy or other anticancer therapy ≤ 4 weeks (6 weeks for
             nitrosourea, antibodies or mitomycin-C) prior to starting study drug.

          -  Patients with acute or chronic pancreatitis.

          -  Patients with impaired cardiac function or clinically significant cardiac diseases.

          -  Patients with another primary malignancy within 3 years prior to starting study
             treatment, with the exception of adequately treated basal cell carcinoma, squamous
             cell carcinoma or other non-melanomatous skin cancer, or in-situ carcinoma of the
             uterine cervix.
Efficacy, Safety, Tolerability, and Pharmacokinetics of Indacaterol Maleate Via Concept1 or Simoon Devices
Condition: Asthma
MeSH terms: Asthma
Intervention: Indacaterol 150 μg via the Concept1 dry-powder inhaler; Indacaterol 60 μg via the Simoon dry-powder inhaler; Indacaterol 120 μg via the Simoon dry-powder inhaler; Placebo to indacaterol via the Concept1 dry-powder inhaler
Intervention description: Indacaterol maleate 150 μg was provided in powder filled capsules with the Concept1 dry-powder inhaler.; Indacaterol 60 μg was provided in powder filled capsules with the Simoon dry-powder inhaler.; Indacaterol 120 μg was provided in powder filled capsules with the Simoon dry-powder inhaler.; Placebo to indacaterol was provided in powder filled capsules with the Concept1 dry-powder inhaler.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: asthma; QAB149; indacaterol; pulmonary function

Summary:

      This study assessed the efficacy, safety, tolerability, and pharmacokinetics of two different
      formulations of indacaterol, one administered via the Concept1 device and one administered
      via the Simoon device. The study aimed to determine whether the novel formulation (Simoon)
      had a similar profile to that of the established formulation (Concept1).
    

Eligibility criteria:

        Inclusion criteria:

          -  Patients with persistent asthma with a forced expiratory volume in 1 second (FEV1) ≥
             50%

          -  Patients using inhaled corticosteroid (with or without long-acting beta agonist)

        Exclusion criteria:

          -  Asthma exacerbations in previous 6 months

          -  Chronic obstructive pulmonary disease (COPD) or other pulmonary disease

          -  Excessive use of short-acting beta agonists

        Other protocol-defined inclusion/exclusion criteria applied to the study.
Fludarabine and Cytarabine in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
Condition: Leukemia; AML; MDS; CML
MeSH terms: Leukemia; Preleukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes
Intervention: Cytarabine; Fludarabine
Intervention description: 0.5 grams/m^2 over 2 hours(+/- 15 minutes) IV every 12 (+/-2) hours for 5 days (4 days in patients > 65 years and 3 days in patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) > 3).; 15 mg/m^2 to be given IV over 15-30 minutes every 12 (+/- 2) hours for 5 days. (4 days in patients > 65 years and 3 days in patients with PS > 3).
Intervention MeSH terms: Cytarabine; Fludarabine; Fludarabine phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 151.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Acute Myelogenous Leukemia; High-Risk Myelodysplastic Syndrome; Chronic myeloid leukemia; CML; Blast crisis; Cytarabine; Ara-C; Cytosar; DepoCyt; Cytosine arabinosine hydrochloride; Arabinosine Hydrochloride; Fludarabine; Fludarabine Phosphate; Fludara; Gemtuzumab Ozogamicin; Mylotarg

Summary:

      The goal of this clinical research study is to learn if the combination of fludarabine and
      cytarabine can help to control Acute Myelogenous Leukemia (AML), High-Risk Myelodysplastic
      Syndrome (MDS) or Chronic Myeloid Leukemia (CML) in myeloid blast crisis. The safety of this
      drug combination will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Sign an Internal Review Board (IRB)-approved informed consent document.

          2. Age >/= 12 years.

          3. Diagnosis of AML [other than acute promyelocytic leukemia (APL)] with
             refractory/relapsed disease. Patients with newly diagnosed AML will be eligible if not
             a candidate for intensive chemotherapy. Patients with high-risk (intermediate-2 or
             high by IPSS or >/=10% blasts) MDS will also be eligible. Patients with chronic
             myeloid leukemia (CML) in blast crisis will be eligible as well.

          4. Eastern Cooperative Oncology Group (ECOG) performance status of </= 3 at study entry.

          5. Organ function as defined below (unless due to leukemia):

             i. Serum creatinine </= 3 mg/dL; ii. Total bilirubin </= 3 mg/dL; iii. Alanine
             aminotransferase (ALT)(Serum Glutamic Pyruvate Transaminase (SGPT)) </= 5 times upper
             limit of normal (ULN) or </= 10 times ULN if related to disease.

          6. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy
             test within 7 days . Men must agree not to father a child and agree to use a condom if
             his partner is of child bearing potential.

        Exclusion Criteria:

          1. Pregnant or breastfeeding females.

          2. Diagnosis of acute promyelocytic leukemia (M3).
Does Welchol (Colesevelam Hydrochloride) Improve Colonic Transit in Diarrhea-predominant Irritable Bowel Syndrome (D-IBS)?
Condition: Irritable Bowel Syndrome; Diarrhea
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Intervention: Colesevelam; Placebo
Intervention description: Welchol (Colesevelam HCL) 1.875 gram twice daily for 12-14 days; Inert capsule matching the study drug, given twice daily
Intervention MeSH terms: Colesevelam Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: bile acid; malabsorption; permeability; diarrhea; IBS; stool

Summary:

      Our hypothesis is that the medication approved for treatment of high blood cholesterol
      levels, Colesevelam HCl (WELCHOL), decreases colonic transit and permeability in patients
      with diarrhea due to irritable bowel syndrome.

      This effect is thought to result from the effect of the medication on bile acids, which can
      cause diarrhea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with D-IBS

          -  Aged 18-65 years

          -  No abdominal surgery (except appendectomy or cholecystectomy as long as patients
             IBS-diarrhea symptoms preceded the cholecystectomy

        Exclusion Criteria:

          -  Participants with known chronic liver disease or Aspartate aminotransferase (AST) or
             Alanine transaminase (ALT) > 2.0 X upper limit of normal

          -  Hypertriglyceridemia and pancreatitis by history

          -  Diabetes or hypoglycemia

          -  Significant coagulation disorder

          -  History of bowel obstruction

          -  Serum triglycerides >500 mg/dL

          -  History of vitamin A, D, E, or K deficiencies
Clinical Study to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension
Condition: Chronic Thromboembolic Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Intervention: Macitentan
Intervention description: Macitentan 10mg, oral tablet, once daily
Intervention MeSH terms: Macitentan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic thromboembolic pulmonary hypertension (CTEPH)

Summary:

      Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used
      for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent

          -  Subject with CTEPH having completed the double-blind (DB) AC-055E201/ MERIT-1 study as
             scheduled (i.e., who remained in the DB study up to Week 24).

          -  Females of childbearing potential must have a negative pre-treatment serum pregnancy
             test, be advised on appropriate methods of contraception, and agree to use 2 reliable
             methods of contraception.

        Exclusion Criteria:

          -  Permanent discontinuation of DB study treatment due to an hepatic adverse event or
             liver aminotransferase abnormalities.

          -  Any known factor (e.g., drug or substance abuse) or disease (e.g., unstable
             psychiatric illness) that, in the opinion of the investigator, may interfere with
             treatment compliance or interpretation of the results, or that may influence the
             ability to comply with any of the study requirements.
A Rollover Study for Patients Who Received Tremelimumab in Other Protocols, to Allow the Patients Access to Tremelimumab Until This Agent Becomes Commercially Available or Development is Discontinued.
Condition: Colorectal Neoplasms; Melanoma; Prostatic Neoplasms; Renal Cell Carcinoma; Neoplasms; Patients Who Have/Have Had Melanoma and Other Tumors
MeSH terms: Neoplasms; Melanoma; Carcinoma, Renal Cell; Colorectal Neoplasms; Prostatic Neoplasms
Intervention: CP-675,206 (Tremelimumab)
Intervention description: 15 mg/kg IV every 3 months as long as required
Intervention MeSH terms: Tremelimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Melanoma and other tumors

Summary:

      This study is intended to provide access to tremelimumab for patients who have previously
      received tremelimumab in a clinical trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject must have already received tremelimumab in another protocol

          -  Females of childbearing potential must agree to practice a form of effective
             contraception for 12 months following any dose of study drug. The definition of
             effective contraception will be based on the judgement of the investigator.

          -  Subject must be willing and able to provide written informed consent and to comply
             with scheduled visits and other trial procedures

        Exclusion Criteria:

          -  None
A Study of Avastin (Bevacizumab) in Combination With Xelox and Tarceva in Patients With Metastatic Colorectal Cancer.
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: bevacizumab [Avastin]; eloxatin; capecitabine [Xeloda]; erlotinib [Tarceva]
Intervention description: Intravenous repeating dose; Intravenous repeating dose; Oral repeating dose; Oral repeating dose
Intervention MeSH terms: Bevacizumab; Capecitabine; Erlotinib Hydrochloride; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of a first-line regimen of Avastin and Xelox
      (Xeloda + Eloxatin) followed by Avastin and Tarceva, in patients with metastatic colorectal
      cancer. Patients will receive 6 x 21 day cycles of treatment with Avastin (7.5mg/kg iv on day
      1), Xeloda (1000mg/m2 po twice daily on days 1 to 14) and Eloxatin (130mg/m2 iv on day 1).
      Patients free of disease progression will then continue with Avastin (7.5mg/kg iv once every
      3 weeks) and Tarceva (150mg po daily). The anticipated time on study treatment is until
      disease progression, and the target sample size is <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  adenocarcinoma of colon or rectum, with metastatic disease;

          -  >=1 measurable lesion.

        Exclusion Criteria:

          -  previous treatment with Avastin or Tarceva;

          -  previous systemic treatment for advanced or metastatic disease;

          -  adjuvant treatment for non-metastatic disease in past 6 months.
A Brentuximab Vedotin Trial for Patients Who Have Previously Participated in a Brentuximab Vedotin Study
Condition: Disease, Hodgkin; Lymphoma, Large-Cell, Anaplastic; Lymphoma, Non-Hodgkin
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, Large-Cell, Anaplastic; Hodgkin Disease
Intervention: brentuximab vedotin
Intervention description: Every 3 weeks by IV infusion (1.2 or 1.8 mg/kg) until disease progression, unacceptable toxicity, or study closure
Intervention MeSH terms: Brentuximab Vedotin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No
Keywords: Antibodies, Monoclonal; Antibody-Drug Conjugate; Antigens, CD30; Drug Therapy; Hematologic Diseases; Immunotherapy; Monomethylauristatin E

Summary:

      This is a multicenter, open-label study to evaluate the safety and efficacy of treatment with
      brentuximab vedotin (SGN-35) in patients who have previously participated in an brentuximab
      vedotin study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participated in a previous brentuximab vedotin study.

          -  CD30-positive hematologic malignancy.

          -  At a minimum, experienced clinical benefit in the prior brentuximab vedotin study. For
             retreatment, patients must have previously achieved either complete or partial
             remission with brentuximab vedotin and experienced disease progression after
             discontinuing the prior brentuximab vedotin study.

        Exclusion Criteria:

        Withdrew consent to participate in any prior brentuximab vedotin study.
A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma.
Condition: Carcinoma, Renal Cell
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: SU011248
Intervention description: 50-mg orally taken daily for 4 weeks and off treatment for 2 weeks until progression or unacceptable toxicity
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To assess the safety and efficacy of SU011248 in patients with metastatic, refractory renal
      cell carcinoma
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cytokine refractory metastatic renal cell carcinoma with clear cell component

          -  Radiographic evidence of disease progression during or within 9 months of completion
             of 1 cytokine therapy

          -  Prior nephrectomy

        Exclusion Criteria:

          -  Prior treatment with any systemic therapy other than 1 cytokine therapy

          -  History of or known brain metastases

          -  Uncontrolled hypertension or other significant cardiac events within the 12 months
             prior to study start