bioihbjkbjnl/mcl2 huggingface dataset:
An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide
Condition: Early Stage HER2+ Breast Cancer
MeSH terms: Breast Neoplasms; Diarrhea
Intervention: Neratinib; Loperamide; Colestipol; Budesonide
Intervention description: 2 g twice daily with or without food for one 28 day cycle; 9 mg extended release tablets once daily with or without food for 28 days
Intervention MeSH terms: Budesonide; Loperamide; Antidiarrheals; Colestipol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 563.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HER2 +; Breast Cancer; Neratinib; Nerlynx; Loperamide; Colestipol; Budesonide

Summary:

      An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients with
      Early-Stage HER2+ Breast Cancer Treated with Neratinib and Loperamide or other prophylactic
      measures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥18; male or female

          -  Early breast cancer (stage I-3c)

          -  Documented HER2+ tumor: HER2 immunohistochemistry (IHC) 3+ or ISH+

          -  Prior course of adjuvant trastuzumab given >2 weeks and ≤1 year from enrollment

          -  No evidence of local/regional recurrence or metastatic disease

          -  Eastern Cooperative Oncology Group (ECOG) status of 0 or 1

          -  Male patients with female partners of childbearing potential must agree and commit to
             use a condom and women of childbearing potential must not be pregnant and must agree
             and commit to the use of a highly effective non-hormonal method of contraception

          -  Left ventricular ejection fraction (LVEF) ≥50% measured by multiple-gated acquisition
             scan (MUGA) or ECHO

        Exclusion Criteria:

          -  Major surgery < 30 days

          -  Chemotherapy, investigational agents, other cancer therapy (except hormonal therapy) <
             14 days

          -  Corrected QT Interval (QTc) >0.450 seconds (males) or >0.470 (females) or other active
             cardiac disease

          -  Significant chronic GI disorder with diarrhea as a major symptom

          -  Active, unresolved infections

          -  Currently pregnant or breast-feeding
Study of Dasatinib in Patients With Chronic Phase Chronic Myeloid Leukemia and a Suboptimal Response to Imatinib
Condition: Leukemia, Myeloid, Chronic
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase
Intervention: Imatinib; Dasatinib
Intervention description: Imatinib tablets administered orally at a dose of 400 mg twice daily. Each 400- mg dose to be taken with a meal and a large glass of water.; Dasatinib tablets administered orally at a dose of 100 mg once daily.
Intervention MeSH terms: Imatinib Mesylate; Dasatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic phase CML, with a suboptimal response after treatment with imatinib

Summary:

      The purpose of this study is to compare the efficacy of dasatinib with that of high-dose
      (800-mg) imatinib in participants with chronic phase chronic myeloid leukemia who achieved
      only a suboptimal response after at least 3 months of monotherapy with 400-mg imatinib. The
      safety of these treatments will also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic phase Ph^+ chronic myeloid leukemia (CML) demonstrating only a suboptimal
             response, defined as a hematologic response that is less than a complete hematologic
             response after at least 3 months of monotherapy with imatinib, 400 mg; a cytogenic
             response (CgR) that is less than a partial CgR (PCgR) after at least 6 months of
             monotherapy with imatinib, 400 mg; a PCgR after at least 12 months of monotherapy with
             imatinib, 400 mg; or less than a major molecular response with a complete CgR after at
             least 18 months of monotherapy with imatinib, 400 mg.

          -  Either gender

          -  Age of 18 years or older

        Exclusion Criteria:

          -  Previous diagnosis of accelerated phase or blast crisis CML

          -  Uncontrolled or significant cardiovascular disease

          -  History of significant bleeding disorder unrelated to CML

          -  Concurrent malignancies

          -  Intolerance of imatinib, 400 mg

          -  Prior treatment with imatinib at a dose higher than 400 mg

          -  Prior stem cell transplantation and/or high-dose chemotherapy for CML
Study to Evaluate the Safety and Efficacy of Naldemedine (S-297995) for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Pain
Condition: Opioid Induced Bowel Dysfunction
MeSH terms: Intestinal Diseases; Gastrointestinal Diseases; Chronic Pain; Opioid-Induced Constipation
Intervention: Naldemedine; Placebo
Intervention description: Tablets or solution for oral administration; Tablets or solution for oral administration
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Chronic pain; Opioid physical dependence

Summary:

      The primary objective of the study is to evaluate the safety of single doses of oral
      naldemedine in adults physically dependent on opioids.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Understand and sign an informed consent form

          -  Males will agree to use an approved double-barrier method of contraception from Day 1
             until 1 month after study completion

          -  Subject tests negative on urine drug test unless the subject has a prescription for
             the drug(s) that test positive

        Exclusion Criteria:

          -  Subjects under opioid therapy for cancer-related pain or for the management of drug
             addiction

          -  Fecal incontinence, irritable bowel syndrome, inflammatory bowel disease, or other
             active medical disorders associated with diarrhea, intermittent loose stools, or
             constipation

          -  Subjects who have participated in any other investigational drug study within 30 days
             prior to Day 1

          -  Prior exposure to S-297995
A Study of LY2409021 in Participants With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY2409021; Sitagliptin; Placebo; Metformin; Sulfonylurea
Intervention description: Administered orally; Administered orally; Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 174.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      The intent of this study is to assess the safety of LY2409021 in participants with Type 2
      diabetes mellitus taking metformin and sulfonylurea as prescribed by their personal
      physician. The study treatment is expected to last 12 months (52 weeks).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have been treated with a stable dose of metformin for at least 3 months and have been
             treated with an optimally effective and stable dose of an sulfonylurea for at least 6
             months prior to screening.

          -  HbA1c value between 7.0% and 10.0%, inclusive.

          -  Body mass index (BMI) between 20 and 45 kilograms/square meter (kg/m^2), inclusive.

        Exclusion Criteria:

          -  Known type 1 diabetes mellitus.

          -  More than 1 episode of severe hypoglycemia within 6 months prior to screening.

          -  Two or more emergency room visits or hospitalizations due to poor glucose control in
             the 6 months prior to screening.

          -  Severe gastrointestinal disease that may significantly impact gastric emptying or
             motility or having undergone gastric bypass or gastric banding surgery.

          -  Previous history or active diagnosis of pancreatitis.

          -  Positive hepatitis B surface antigen or hepatitis C antibody.

          -  Clinical signs or symptoms of liver disease, or hepatic aminotransferases
             (aminotransferase or alanine aminotransferase) greater than 2.0× upper limit of normal
             (ULN) or elevated alkaline phosphatase (greater than ULN) unrelated to bone metabolic
             disease.

          -  Elevated total bilirubin level (greater than ULN), clinically suspicious
             signs/symptoms of cirrhosis or history of cirrhosis.

          -  Current diagnosis, personal history of neuroendocrine tumors, family history of any
             type of multiple endocrine neoplasia (MEN), or Von Hippel-Lindau.

          -  Contraindications for magnetic resonance imaging.
A Study to Assess the Efficacy and Safety of Lenalidomide in Combination With Cetuximab in Pre-treated Patients With KRAS Mutant Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: cetuximab; lenalidomide
Intervention description: Intravenous infusions of cetuximab (400 mg/m^2 Cycle 1 Day 1, thereafter 250 mg/m^2), administered on days 1, 8, 15 and 22 of each 28 day cycle.; Daily oral lenalidomide 25mg on days 1 to 28 of each 28 day cycle
Intervention MeSH terms: Lenalidomide; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Colorectal cancer; Revlimid; Lenalidomide; Cetuximab; Erbitux; KRAS

Summary:

      The purpose of this study is to determine whether lenalidomide in combination with cetuximab
      is safe and effective in patients with KRAS mutant colorectal cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Metastatic colorectal adenocarcinoma.

          2. Confirmed K-RAS mutant tumor

          3. Disease progression on oxaliplatin- AND irinotecan-containing regimens, with at least
             one of these regimens containing bevacizumab.

          4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.

        Exclusion Criteria:

          1. Use of chemotherapy, hormonal therapy, immunotherapy or any other cancer or
             experimental treatment ≤ 28 days prior to the first day of the first cycle.

          2. Radiotherapy for up to ≥ 30% of the bone marrow.

          3. Surgery ≤ 28 days before day 1 of the first cycle (minimally invasive interventions
             for diagnostic purposes or disease staging are permitted).

          4. Previous treatment with cetuximab, panitumumab, pomalidomide (CC-4047), lenalidomide
             or thalidomide.

          5. Untreated, symptomatic brain metastases (brain imaging not required).

          6. Venous thromboembolism ≤ 6 months before day1 of the first cycle.

          7. Current congestive heart failure (classes II to IV of the New York Heart Association).

          8. Myocardial infarction ≤ 12 months before day1 of the first cycle.

          9. Uncontrolled hypertension.
Effects of Human Leptin Replacement
Condition: Obesity; Metabolic Syndrome; Diabetes
MeSH terms: Metabolic Syndrome
Intervention: Recombinant methionyl human leptin
Intervention description: Recombinant methionyl human leptin, subcutaneous, once a day, 0.02 to 0.04 mg/kg (adjusted according to weight loss), indeterminate duration.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Congenital leptin deficiency; Obesity; Metabolic syndrome; Diabetes

Summary:

      This study will test the hypothesis that leptin contributes to the regulation of the dynamics
      of human endocrine function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Congenital leptin deficiency (these are only 3 adult individuals in the world that
             have been identified as leptin-naïve thus far).

        Exclusion Criteria:

          -  Pregnant, trying to become pregnant, breast-feeding an infant or sexually active
             women, not using contraception.

          -  Subjects with hemoglobin levels below 12 g/dl.

          -  Subjects whose body contains a ferromagnetic implanted device that might produce a
             safety hazard during fMRI.
Safety and Immunogenicity of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in HIV Infected Patients
Condition: HIV Infections
MeSH terms: Smallpox
Intervention: IMVAMUNE (MVA-BN)
Intervention description: 2 immunizations, four weeks apart: 1 x 10E8 TCID50, subcutaneous
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 581.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HIV; treatment experienced; treatment vaccinia naive

Summary:

      The purpose of this study is to gather information on the safety and immunogenicity of an
      investigational smallpox vaccine in HIV infected populations. Subjects will receive two
      vaccinations
    

Eligibility criteria:

        -  Genders eligible for Study: Both

          -  Age: between 18 and 55 years

          -  Healthy volunteers are accepted

        Inclusion Criteria:

          -  Subjects tested positive for HIV-1 infection (HIV-infected subjects).

          -  Subjects that are tested negative for HIV (Healthy subjects).

          -  Either on stable antiretroviral therapy or not on antiretroviral therapy.

          -  CD4 cells > = 200 - 750/µl.

          -  Subjects must be in good general health except for HIV infection.

          -  Women must not be pregnant and use an acceptable method of contraception.

        Exclusion Criteria:

          -  Impairment of immunologic function (other than HIV infection).

          -  History of coronary heart disease, myocardial infarction, angina, congestive heart
             failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood
             pressure.

          -  Uncontrolled serious infection.

          -  History of or active autoimmune disease.

          -  History or clinical manifestation of clinically significant and severe hematological,
             renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal
             disorders.

          -  History of an immediate family member (father, mother, brother, or sister) who has had
             onset of ischemic heart disease before the age of 50 years.

          -  High risk of developing a myocardial infarction or coronary death.

          -  History of intravenous drug abuse (within the last 12 months).

          -  Known allergy to egg or aminoglycoside (gentamicin).

          -  History of anaphylaxis or severe allergic reaction.

          -  Subjects undergoing treatment for tuberculosis infection or disease.

          -  Chronic administration of systemic immuno-suppressants.
Paediatric Safety Study in Cat-PAD
Condition: Rhinoconjunctivitis
MeSH terms: Conjunctivitis
Intervention: Cat-PAD; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Care Provider)
Enrollment: 16.0
Sex: All
Minimum age: 5 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Cat Allergy; Rhinoconjunctivitis

Summary:

      Study to Assess the Safety of Cat-PAD in Cat Allergic Paediatric Subjects
    

Eligibility criteria:

        -  Inclusion Criteria

               -  Male or female, aged 5-12 years.

               -  Moderate to severe rhinoconjunctivitis on exposure to cats for at least 2 years.

               -  Subjects may optionally also have GINA Step 1 controlled asthma.

               -  Positive skin prick test to cat hair.

               -  Cat dander specific IgE ≥0.35 kU/L.

          -  Exclusion Criteria

               -  Asthma falling under the GINA definitions "partly controlled" and "uncontrolled"
                  or Steps 2 to 5.

               -  FEV1 <80% of predicted.

               -  Clinically relevant abnormalities detected on physical examination.

               -  History of severe drug allergy, severe angioedema or anaphylactic reaction to
                  food.
A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: ABBV-3067; Placebo ABBV-3067; ABBV-2222; Placebo ABBV-2222
Intervention description: Tablet taken orally.; Tablet taken orally.; Capsule taken orally.; Capsule taken orally.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cystic Fibrosis; ABBV-3067; ABBV-2222, F508del Mutation

Summary:

      This study will evaluate the safety, tolerability, and efficacy of ABBV-3067 given alone and
      in combination with various doses of ABBV-2222 in adults with Cystic Fibrosis who are
      homozygous for the F508del mutation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed clinical diagnosis of Cystic Fibrosis (CF) who are homozygous for the
             F508del CF transmembrane conductance regulator (CFTR) mutation

          -  Stable pulmonary status

          -  Lung function >= 40 and <= 90% of predicted normal for age, gender and height at
             Screening

        Exclusion Criteria:

          -  History of solid organ or hematopoietic transplant

          -  Cirrhosis with portal hypertension

          -  Use of CFTR modulator therapy within 60 days prior to Screening
A Two Week Study to Assess the Tolerability of AZD9668 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: AZD9668; Placebo
Intervention description: 30mg oral tablets twice daily (bid) for 14 days; Matched placebo to 30mg oral tablet twice daily (bid) for 14 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 18.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Chronic; obstructive; pulmonary; lung; respiratory disease; tolerability; placebo-controlled; pharmacokinetics; COPD

Summary:

      The purpose of this study is to assess the tolerability (effect of drug on body) and
      pharmacokinetics (effect of body on drug) of AZD9668 in patients with mild to moderate COPD
    

Eligibility criteria:

        Inclusion Criteria:

          -  Mild to moderate COPD

          -  Smokers or ex-smokers

          -  post-menopausal females

        Exclusion Criteria:

          -  Past history or current evidence of clinically significant heart disease

          -  Lung disease other than COPD

          -  Treatment with systemic steroids within 8 weeks of study visit 2

          -  Treatment with antibiotics within 4 weeks of study visit 1 or study visit 2
Heart Rate Variability in Response to Metformin Challenge
Condition: Fibromyalgia; Mitochondrial Diseases; Movement Disorders; Diabetes Mellitus, Type 2
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Movement Disorders; Diabetes Mellitus, Type 2; Mitochondrial Diseases
Intervention: Metformin
Intervention description: 500 mg orally after baseline testing of heart rate
Intervention MeSH terms: Metformin
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: metformin; mitochondria; complex 1; fibromyalgia; neurogenic pain; diabetes; tardive dyskinesia; heart rate variability

Summary:

      Diseases caused by brain energy supply defects can be innate (fibromyalgia secondary to
      familial mitochondrial disorders) or acquired (tardive dyskinesia or weight gain associated
      with prolonged antipsychotic use). Patients with these possible mitochondrial disorders will
      provide a baseline resting heart rate sample, ingest low-dose metformin (500 mg), and then
      provide an additional sample 2 hours later.
    

Eligibility criteria:

        Inclusion Criteria:

        EITHER chronic neurogenic pain meeting American College of Rheumatology criteria for
        fibromyalgia or previous/current exposure to antipsychotic medications

        Exclusion Criteria:

          -  recent infection,

          -  renal failure,

          -  pre-existing cardiac disease,

          -  chronic obstructive pulmonary disease

          -  inability to participate in informed consent,

          -  lack of transport to return home from study site,

          -  severe fasting intolerance or hypoglycemia,

          -  history of stroke-alike episode,

          -  uncontrolled migraine or cyclic vomiting,

          -  diabetes on insulin or sulfonylurea,

          -  non-English speaker,

          -  medications with strong effects on baseline heart rate variability