bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Acute Vaginal Candidiasis (Yeast Infection)
Condition: Candidiasis, Vulvovaginal
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal
Intervention: VT-1161; Fluconazole
Intervention MeSH terms: Fluconazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 55.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if the novel oral agent VT-1161 is safe and
      effective in treating patients with acute vulvovaginal candidiasis (also referred to as yeast
      infection). VT-1161 has been designed to inhibit CYP51, an enzyme essential for fungal
      growth. Inhibition of CYP51 results in the accumulation of chemicals know to be toxic to the
      fungus. CYP51 is the molecular target of the class of drugs referred to as 'azole
      antifungals'. All currently approved azole drugs have poor selectivity for CYP51 and this
      results in many of the side effects associated with the azole antifungals. The safety profile
      of the class similarly limits use in chronic treatment of non-life-threatening fungal
      infections. VT-1161 has been design to be safer and more active against the fungal species
      typically responsible for vaginal yeast infections (i.e. vulvovaginal candidiasis).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Females ≥18 and <65 years

          -  Clinical diagnosis of symptomatic acute VVC

          -  Positive KOH .At least one vulvovaginal sign (vulvovaginal erythema, edema, or
             excoriation).

          -  At least one vulvovaginal symptom (vulvovaginal itching, burning, or irritation)

          -  A minimum composite vulvovaginal signs and symptoms score of ≥6

          -  must be be able to swallow capsules

        Exclusion Criteria:

          -  Evidence of major organ system disease

          -  History of cervical cancer

          -  History of diabetes mellitus

          -  Pregnant

          -  Recent use of systemic antifungal drugs or systemic antimicrobial therapy for any
             reason

          -  Recent use of drugs to treat vaginal infections

          -  Recent use of immunosuppressive therapies
Anti-thrombin III (ATIII) vs Placebo in Children (<7mo) Undergoing Open Congenital Cardiac Surgery
Condition: ATIII Deficiency
MeSH terms: Antithrombin III Deficiency
Intervention: Anti-thrombin III; Placebo
Intervention description: Intraoperatively- (correcting to 100%) according to the following formula:
Units required = ((100%- baseline ATIII level*%) X body weight)/1.4
expressed as a % normal level based on functional ATIII assay; Normal saline placebo
Intervention MeSH terms: Antithrombin III; Antithrombins; Thrombin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 45.0
Sex: All
Maximum age: 7 Months
Healthy volunteers: No

Summary:

      The purpose of this study is to test whether the administration of ATIII during the
      intra-operative period results in improved anticoagulation for cardiopulmonary bypass (CPB)
      and an attenuation of the activation of the coagulation cascade, as represented by a decrease
      in fibrin degradation products. The investigators believe this benefit would extend into the
      post-operative period resulting in a decreased incidence of thrombosis generation, as
      represented by a decrease in fibrin degradation products in the ICU period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients less than 7 months of age going for cardiac surgery that will require
             cardiopulmonary bypass (CPB) with a documented ATIII level below 70%

        Exclusion Criteria:

          -  Less than 2.5kg

          -  Known or suspected hereditary ATIII deficiency (family history of venous thrombosis
             with decreased plasma levels of ATIII and no other potential causes of acquired
             decreased ATIII)

          -  On Ecmo (extracorporeal membrane oxygenation ) at time of surgery

          -  Known history of thrombosis

          -  Renal failure as described by the pediatric RIFLE criteria

          -  H/o intracranial hemorrhage

          -  Prematurity less than 37 weeks estimated gestational age

          -  Previously diagnosed pro-thrombotic or hemorrhagic disorder

          -  Prior ATIII supplementation

          -  Prior therapeutic anticoagulant use
Asacol Acute Diverticulitis(DIVA)Study
Condition: Diverticulitis
MeSH terms: Diverticulitis
Intervention: Mesalamine; Probiotic; Placebo; Dietary Advice; Antibiotic for Diverticulitis
Intervention description: 6 - 400 mg tablets once daily; Once capsule daily Bifidobacterium infantis 35624 added at Visit 2 (Day 10 + 4 days); 6 placebo tablets for first 10 (+4) days followed by once daily placebo tablets.; Dietary advice; Physician recommended antibiotic for Diverticulitis taken for 10-14 days. Antibiotic not specified for study.
Intervention MeSH terms: Anti-Bacterial Agents; Mesalamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 117.0
Sex: All
Minimum age: 35 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether Asacol® 2.4 g/day (400 mg Mesalamine) is
      safe and effective in the treatment of diverticulitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A clinical diagnosis of acute diverticulitis

          -  Female patients must be postmenopausal (at least 1 year without spontaneous menses) or
             surgically sterile or have a negative urine pregnancy test and practice acceptable
             contraception (e.g., abstinence; oral, intramuscular, or implanted hormonal
             contraception [at least 3 months prior to enrollment]; 2-barrier methods [e.g.,
             condom, diaphragm, or spermicide]; intrauterine device or verbal report of partner
             with history of non-reversed vasectomy)

          -  Willing and able to participate in the study and provide a signed informed consent

        Exclusion Criteria:

          -  Presence of diverticular complications (e.g., fistula, abscess, obstruction,
             stenosis);

          -  Active or recent history (within 6 months) of a peptic ulcer;

          -  Prior history of irritable bowel syndrome (IBS), as determined by the Investigator;

          -  History of major abdominal surgery (as determined by the Investigator);

          -  History of GI surgery within 3 months of diagnosis of acute diverticulitis;

          -  History of immunocompromising disease, human immunodeficiency virus (HIV) infection,
             or acquired immunodeficiency syndrome (AIDS);

          -  If female patient, active or recent history of endometriosis or dysmenorrhea;

          -  Received a dose of a product that contains, or is metabolized to, mesalamine by any
             route within 4 weeks before the screening visit;
Effect of Vitamin D Repletion on Insulin Resistance and Systemic Inflammation
Condition: Insulin Resistance
MeSH terms: Insulin Resistance; Inflammation
Intervention: Vitamin D; Placebo
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 19.0
Sex: All
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Glucose Metabolism Disorders; Insulin Resistance; Endocrine System; Vitamin D

Summary:

      The purpose of this research is to study the effects of Vitamin D supplementation on the
      body's response to insulin (a hormone that controls blood sugar), on inflammation, and on
      specific cells and processes in fat tissue.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Serum 25(OH)D<20ng/ml

          -  Insulin Resistant based on HOMA-IR score of >3

          -  Able and willing to provide informed consent

          -  BMI 20-35

        Exclusion Criteria:

          -  HIV/AIDS

          -  History of any cancer

          -  Sarcoidosis

          -  Alcohol or substance abuse

          -  Cushing's syndrome

          -  Primary hyperparathyroidism

          -  Nephrolithiasis

          -  Pregnancy or breastfeeding

          -  Regular visits to a tanning salon

          -  Hypercalcemia or hypocalcemia

          -  Untreated or uncontrolled hypertension

          -  Any chronic illness requiring medication, other than arthritis, hypertension and
             hyperlipidemia
Effects of Varenicline on Cigarette Self Administration
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: Varenicline; Placebo
Intervention description: 4 doses of Varenicline. 1 capsule of either dose (0mg, 0.5mg, 1mg, 2 mg) in the morning on days at least 5 days apart.; 1 dose of placebo
Intervention MeSH terms: Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 21 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The investigators hypothesize that varenicline will dose dependently attenuate the subjective
      effects of cigarettes after a period of abstinence. Also, treatment with varenicline will
      dose dependently weaken the severity of nicotine withdrawal symptoms. Thirdly, we hypothesize
      that treatment with varenicline will dose dependently decrease cigarette self-administration
      in the model proposed.
    

Eligibility criteria:

        Inclusion Criteria:

          1. A diagnosis of nicotine dependence with physiological dependence, smoking at least 15
             cigarettes/day during the last 3 months.

          2. Not interested in treatment

          3. Medically healthy on the basis of physical examination and medical history, vital
             signs, EKG and laboratory tests, with a negative pregnancy test for females.

          4. Able to perform study procedures

          5. Males or females between the ages of 21-45 yrs

          6. Female participants agree to use an effective method of birth control during the
             course of the study

        Exclusion Criteria:

          1. A diagnosis of abuse or dependence on alcohol or drugs other than nicotine

          2. Current Axis I diagnosis or current treatment with psychotropic medications (within
             last 3 months)

          3. Lifetime history of schizophrenia or other psychotic disorders, bipolar disorder, or
             anxiety disorders

          4. Currently seeking treatment for nicotine dependence

          5. Participants on parole or probation

          6. History of significant recent violent behavior

          7. Blood pressure > 150/90

          8. History of allergic reaction to any of the study medications
Trial of Paclitaxel, Bevacizumab, and Enzastaurin Versus Paclitaxel, Bevacizumab and Placebo for Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Enzastaurin; Bevacizumab; Paclitaxel; Placebo
Intervention description: 1125 milligrams (mg) loading dose on Day 1 of Cycle 1 only then 500 mg oral once daily, until disease progression; 10 milligrams per kilogram (mg/kg) intravenously, Days 1 and 15 every 28 days, until disease progression; 90 milligrams per square meter (mg/m^2), intravenously, Days 1 ,8, and 15 every 28 days until disease progression; Oral, daily, until disease progression
Intervention MeSH terms: Paclitaxel; Bevacizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine efficacy and safety of paclitaxel, bevacizumab and
      enzastaurin versus paclitaxel, bevacizumab, and placebo in participants who are diagnosed
      with locally recurrent or metastatic breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have signed an inform consent document

          -  Have histologic or cytologic diagnosis of breast cancer with evidence of unresectable
             locally recurrent or metastatic disease

          -  Have not received any prior chemotherapy for locally recurrent or metastatic disease

          -  Have not had adjuvant or neoadjuvant taxane therapy within 12 months prior to
             assignment to study treatment

          -  Age 18 years or older at time of informed consent

        Exclusion Criteria:

          -  Have any clinical evidence of central nervous system (CNS) metastases

          -  Have a history of seizure

          -  Have had a major surgical procedure within 4 weeks prior to assignment to study
             treatment

          -  Have had a minor surgical procedure, placement of an access device, or fine needle
             aspiration within 7 days prior to assignment to study treatment

          -  Have symptomatic peripheral vascular disease
Open Label Study of Subcutaneous Homoharringtonine (Omacetaxine Mepesuccinate) in Patients With Advanced CML
Condition: Chronic Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Intervention: Omacetaxine mepesuccinate
Intervention description: Induction: 1.25mg/m^2 subcutaneously twice daily for 14 consecutive days, every 28 days.
Maintenance: 1.25mg/m^2 subcutaneously twice daily for 7 consecutive days, every 28 days.
Response targets during induction vary by chronic myeloid leukemia (CML) subclass (chronic, accelerated, or blast phase). Participants will complete at least one cycle (14 days treatment of a 28 day cycle) of induction therapy before changing to maintenance therapy. Participants not demonstrating evidence of clinical response after 6 induction cycles will be considered for removal from the study.
Intervention MeSH terms: Homoharringtonine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CML; HHT; Homoharringtonine; Omacetaxine

Summary:

      A Phase II open-label trial of subcutaneous HHT (omacetaxine mepesuccinate) in the treatment
      of patients who are resistant to or intolerant to Tyrosine Kinase Inhibitors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients, age 18 years or older

          -  Philadelphia chromosome (Ph) positive chronic myelogenous leukemia in either chronic,
             accelerated, or blast phase

          -  Patients will have either failed, demonstrated intolerance, or a combination of prior
             failure and intolerance, to prior treatments with at least two tyrosine kinase
             inhibitors (TKI's). Failure of TKI treatment may either be primary (never achieved a
             response) or secondary resistance (loss of response).

          -  Acceptable Renal and Liver Function

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

          -  Sexually active patients and their partners must use an effective double barrier
             method of contraception

        Exclusion Criteria:

          -  New York Heart Association classification (NYHA) class III or IV heart disease, active
             ischemia or any other uncontrolled cardiac condition

          -  Myocardial infarction in the previous 12 weeks.

          -  Other concurrent illness which would preclude study conduct and assessment

          -  uncontrolled and active infection, and positive HIV or positive HTLV I/II status,
             whether on treatment or not.

          -  Pregnant or lactating.

          -  Any medical or psychiatric condition, which may compromise the ability to give written
             informed consent or to comply with the study protocol.

          -  Lymphoid Ph+ blast crisis

          -  Patient is enrolled in another clinical investigation within 30 days of enrollment or
             is receiving another investigational agent
Standard Idarubicin and Cytarabine for the Treatment of Acute Myeloid Leukemia (AML)
Condition: Leukemia; Acute Myeloid Leukemia; AML
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Cytarabine; Idarubicin
Intervention description: 1.5 g/m2 IV over 24 hours daily on day 1-4 (age <60 years) or days 1-3 (age > 60 years).; 12 mg/m2 IV over 1 hour daily x 3 (days 1-3)
Intervention MeSH terms: Cytarabine; Idarubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 175.0
Sex: All
Minimum age: 15 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Cytarabine, Idarubicin; Leukemia; Acute Myeloid Leukemia; AML; Cytarabine; Idarubicin

Summary:

      The goal of this clinical research study is to find out if standard chemotherapy given with
      idarubicin and Cytarabine (ara-C) can help to control AML.

      Objectives:

      To determine the complete response (CR) rate, event-free survival (EFS) and overall survival
      (OS) of patients with newly diagnosed acute myeloid leukemia (AML) receiving standard
      combination chemotherapy with Idarubicin and cytarabine.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of 1) AML (WHO classification definition of >/= 20% blasts). Patients with
             M6 AML with less than 20% blasts are eligible.

          2. Patients aged 15 to 75 years are eligible. Patients must be chemo-naïve, i.e. not have
             received any prior chemotherapy (except hydrea) for AML. They could have received
             transfusions, hematopoietic growth factors or vitamins. Temporary measures such as
             pheresis or hydrea (0.5 to 5g daily or more for up to 3 days) are allowed .

          3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, 2, or 3 at
             screening.

          4. Serum biochemical values with the following limits: - creatinine </= 2.0 mg/dl - total
             bilirubin </= 2.0 mg/dL, unless increase is due to hemolysis - transaminases (SG PT)
             </= 3x upper limit of normal (ULN)

          5. Ability to understand and provide signed informed consent.

        Exclusion Criteria:

          1. Subjects with Acute Promyelocytic Leukemia (APL).

          2. Presence of active systemic infection.

          3. Any coexisting medical condition that in the judgment of the treating physician is
             likely to interfere with study procedures or results.

          4. Nursing women, women of childbearing potential with positive urine pregnancy test, or
             women of childbearing potential who are not willing to maintain adequate contraception
             (such as birth control pills, intrauterine device (IUD), diaphragm, abstinence, or
             condoms by their partner) over the entire course of the study.
Efficacy and Safety of BI 10773 in Combination With Insulin in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: BI 10773 placebo; BI 10773 low dose; BI 10773 high dose; BI 10773 placebo
Intervention description: BI 10773 placebo; BI 10773 low dose; BI 10773 high dose; BI 10773 placebo
Intervention MeSH terms: Empagliflozin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 494.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of the current study is to investigate the efficacy, safety and tolerability of
      BI 10773 at two different doses compared to placebo during long term treatment (78 weeks) in
      combination with basal insulin in patients with type 2 diabetes mellitus with insufficient
      glycaemic control.
    

Eligibility criteria:

        Inclusion criteria:

          1. Signed and dated written informed consent by date of Visit 1 in accordance with Good
             Clinical Practice (GCP) and local legislation

          2. Male and female patients with a diagnosis of Type 2 Diabetes Mellitus treated with a
             stable dose of basal insulin with or without concomitant metformin and / or
             sulfonylurea.

          3. Glycosylated hemoglobin A1c (Type A, subtype 1c) of >7.0% and < or = 10% at Visit 1
             (screening)

          4. Suitability for trial participation according to investigator's judgment (evaluating
             all alternative treatment options and in consideration of the patient completing the
             study)

          5. Age > or =18 years at Visit 1 (screening)

          6. BMI < or = 45 kg/m2 (Body Mass Index) at Visit 1 (screening)

        Exclusion criteria:

          1. Patients with poorly controlled hyperglycemia

          2. Frequent (at the discretion of the investigator) episodes of hypoglycemic events on
             basal insulin therapy

          3. MI, stroke, or TIA within 3 months prior to obtaining informed consent

          4. Impaired hepatic or renal function; gastric surgery; cancer within the last 5 years;
             blood dyscrasias

        6. Treatment with other anti-diabetics, anti-obesity medications, steroids or thyroid
        hormones, participation in another trial with an investigational drug 7. Pre-menopausal
        women on insufficient birth control 8. Alcohol or drug abuse