bioihbjkbjnl/mcl2 huggingface dataset:
A Phase II Study of Pioglitazone for Patients With Cancer of the Pancreas
Condition: Cancer of the Pancreas
MeSH terms: Pancreatic Neoplasms
Intervention: Pioglitazone
Intervention MeSH terms: Pioglitazone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is being done to determine whether or not addition of the oral medication,
      pioglitazone to standard chemotherapy, results in improvement of blood tests that measure the
      body's ability to utilize sugar (glucose and insulin metabolism). In addition the
      investigators want to determine whether or not treatment with pioglitazone results in (1)
      improvement in the size of the tumor, (2) weight gain, (3) improved ability to function
      during the day and (4) quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent

          -  Histologically proven adenocarcinoma of the pancreas

          -  Radiologically measurable disease

          -  ECOG functional status 0-2

        Exclusion Criteria:

          -  Prior radiation therapy for pancreatic cancer If chemotherapy is planned, new
             chemotherapy regimen should have started more than 14 days prior to enrollment

          -  Surgery or radiation planned within 8 weeks of starting therapy

          -  Prior exposure to Thiazolidinedione (TZD) therapy in the past 12 months

          -  Hypersensitivity of TZD

          -  New York heart association class III/IV heart failure.

          -  Known HIV positive

          -  Pregnant or lactating women

          -  History of, or active bladder cancer

          -  Inadequate hepatic function documented within 14 days of enrollment

          -  Total bilirubin level > 1.5 x ULN

          -  AST and ALT > 2.5 x ULN, unless there are liver metastases in which case AST and ALT
             or > 5 x ULN
Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease (US202)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: T-817MA-H; T-817MA-L; Placebo
Intervention description: 224 mg or 448 mg T-817 MA once daily; 224 mg T-817 MA once daily; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 482.0
Sex: All
Minimum age: 55 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Alzheimer's Disease; Alzheimer's

Summary:

      The primary objective is to evaluate the efficacy of T-817MA as measured by ADAS-cog and
      ADCS-CGIC.

      The secondary objectives are:

        -  To evaluate the safety and tolerability of T-817MA measured by clinical safety
           laboratories, physical examinations, ECGs and solicitation of adverse events.

        -  To evaluate the efficacy of T-817MA as measured by ADCS-ADL, FAQ, Neuropsychiatric
           Inventory (NPI) and Mini-mental State Examination (MMSE).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female (post-menopausal or surgically sterile)

          -  Patients with Mild to moderate Alzheimer's disease who are receiving donepezil
             (Aricept®) or rivastigmine transdermal system (Exelon® Patch), . Memantine (Namenda®)
             is allowed only when prescribed in combination with donepezil or rivastigmine
             transdermal system.

          -  Age 55 to 85 inclusive

          -  Patients must be living in the community

          -  Patients must have an eligible informant or study partner (caregiver)

          -  Patients and eligible informant or study partner (caregiver) must be able to read and
             understand English.

          -  Informed consent obtained from both the patient and the caregiver

        Exclusion Criteria:

          -  Patients with clinically significant cardiac, hepatic or renal impairment

          -  Patient have a dementia not of the Alzheimer's type etc (According to the protocol)

          -  Patients who are taking any drug other than donepezil or rivastigmine transdermal
             system for Alzheimer's disease, including olal rivastigmine (Exelon®), galantamine
             (Razadyne®)
Fecal Microbiota Transplantation for Pancreatitis
Condition: Acute Pancreatitis; Intestinal Bacteria Flora Disturbance; Intestinal Dysfunction; Fecal Microbiota Transplantation
MeSH terms: Pancreatitis
Intervention: Fecal Microbiota Transplantation; normal saline
Intervention description: FMT via a nasoduodenal tube with fresh bacteria from healthy donor; Normal saline via a nasoduodenal tube.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Severe acute pancreatitis; Fecal Microbiota Transplantation; Intestinal barrier dysfunction; Intestinal flora

Summary:

      The intestinal microbiota plays a pivotal role in the maintenance of intestinal homeostasis
      and protecting the gut against pathogens by competing for nutrients, creating the intestinal
      biological barrier and modulating the host immune system.After the onset of acute
      pancreatitis,the intestinal hypoperfusion and the release of inflammatory mediators result in
      intestinal barrier dysfunction and intestinal bacteria dysbiosis.This leads to Bacterial and
      endotoxin translocation, which may cause infectious complications which are major causes of
      death in SAP patients.Recently,FMT was shown its efficacy in the treatment of
      gastrointestinal(GI) diseases and non-GI disorders associated with Intestinal flora
      disturbance by re-establishing the damaged Intestinal Bacteria homeostasis.However,the
      mechanism by which FMT results in cure of diseases has been poorly understood.This study aims
      to investigate the therapeutic potential of FMT for SAP patients with intestinal barrier
      dysfunction.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of acute pancreatitis from the First Affiliated Hospital of Nanchang
             University according to the Classification of acute pancreatitis-2012: revision of the
             Atlanta classification and definitions by international consensus

          2. Onset of pancreatitis within <=2 weeks

          3. complicated with gastrointestinal failure. Gastrointestinal failure was defined if the
             patients were complicated with obvious abdominal distention, abdominal rumbling sound
             weakening or disappearance, no self-defecation as well as intra-abdominal
             hypertension.

        Exclusion Criteria:

          1. SAP complicated by Gastrointestinal bleeding or Intestinal fistula

          2. Pregnancy and lactation women

          3. Not signed the informed consent

          4. Diabetes and autoimmune diseases

          5. Multiple organ failure. Organ failure was defined as a score of 2 or more using the
             modified Marshall scoring system including respiratory failure, renal failure and
             circulatory.
Fulvestrant in Treating Patients With Recurrent, Persistent, or Metastatic Endometrial Cancer
Condition: Recurrent Uterine Corpus Carcinoma; Stage III Uterine Corpus Cancer AJCC v7; Stage IV Uterine Corpus Cancer AJCC v7
MeSH terms: Carcinoma; Recurrence
Intervention: Fulvestrant
Intervention description: Given intramuscularly
Intervention MeSH terms: Fulvestrant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 67.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying fulvestrant to see how well it works in treating patients
      with recurrent, persistent, or metastatic endometrial cancer. Estrogen can stimulate the
      growth of cancer cells. Hormone therapy using fulvestrant may fight cancer by blocking the
      uptake of estrogen by the tumor cells.
    

Eligibility criteria:

        Criteria:

          -  Histologically confirmed recurrent, persistent, or metastatic endometrial cancer that
             is not curable with surgery or radiotherapy

          -  Estrogen receptor (ER) and progesterone receptor status known by immunohistochemistry

               -  ER positive or negative allowed

          -  Measurable disease:

               -  At least 1 target lesion not within a previously irradiated field OR irradiated
                  target lesion with clear disease progression

               -  At least 20 mm by conventional techniques, including palpation, x-ray, CT scan,
                  MRI, OR at least 10 mm by spiral CT scan

          -  Performance status:

               -  GOG 0-1

          -  Hematopoietic:

               -  Absolute neutrophil count >= 1,500/mm^3

               -  Platelet count >= 100,000/mm^3

               -  No prior bleeding diathesis (disseminated intravascular coagulation, clotting
                  factor deficiency, or requirement for anticoagulants)

          -  Hepatic:

               -  Bilirubin =< 1.5 times upper limit of normal (ULN)

               -  SGOT =< 3 times ULN

               -  Alkaline phosphatase =< 3 times ULN

          -  Renal:

               -  Creatinine =< 2 mg/dL

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No hypersensitivity to castor oil

          -  No other concurrent malignancy except nonmelanoma skin cancer

          -  No other prior malignancy within past 5 years

          -  No prior chemotherapy for persistent, recurrent, or metastatic endometrial cancer

          -  No more than 1 prior chemotherapy regimen for newly diagnosed endometrial cancer that
             has subsequently recurred

          -  At least 3 weeks since prior hormonal therapy and recovered

          -  At least 3 weeks since prior radiotherapy and recovered

          -  At least 3 weeks since prior surgery and recovered
Pharmacokinetic, Safety and Tolerability Study of Aclidinium/Formoterol Fixed Dose Combination and Formoterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Aclidinium/formoterol 400/12μg; Formoterol
Intervention description: Aclidinium/formoterol 400/12μg fixed dose combination (FDC), one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) on Day 5 via the Almirall inhaler; Formoterol 12 μg one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) on Day 5 via the Foradil® Aerolizer®
Intervention MeSH terms: Formoterol Fumarate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; Chronic Obstructive Pulmonary Disease; Chronic Bronchitis; Emphysema; Airflow Obstruction, Chronic; Chronic Airflow Obstruction; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease

Summary:

      The purpose of this Phase II study is to evaluate the pharmacokinetics, safety, and
      tolerability of aclidinium/formoterol fixed dose combination (FDC 400/12 μg via the Almirall
      Inhaler and formoterol 12 μg via the Foradil® Aerolizer®, both administered twice daily for
      five days to patients with moderate to severe COPD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current or former cigarette smokers with a cigarette smoking history of at least 10
             pack-years

          -  A diagnosis of stable moderate to severe COPD and stable airway obstruction as defined
             by the Global Initiative for Chronic Obstructive Lung Disease guidelines and stable
             airway obstruction.

        Exclusion Criteria:

          -  Patients who have been hospitalized for an acute COPD exacerbation within three months
             prior to Screening

          -  Any respiratory tract infection (including the upper respiratory tract) or COPD
             exacerbation in the six weeks before Screening

          -  Patients with any clinically significant respiratory conditions other than COPD

          -  Clinical history that suggests that the patient has asthma as opposed to COPD

          -  Chronic use of oxygen therapy ≥ 15 hours/day

          -  Patients with clinically significant cardiovascular conditions

          -  Patients with a history of hypersensitivity reaction to inhaled anticholinergics,
             beta-2 agonists, sympathomimetic amines, or inhaled medications
Phase 2 Study of TMX-049 in Subjects With Type 2 Diabetes and Albuminuria
Condition: Diabetic Kidney Disease
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Albuminuria
Intervention: TMX-049; Placebo
Intervention description: A certain dose of TMX-049 to be taken orally, once daily; Matching placebo to be taken orally, once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic Kidney Disease; XO inhibitor; UACR

Summary:

      The primary objective of this study is to assess the effect of 2 dose levels of TMX-049 on
      urinary albumin excretion in subjects with Type 2 diabetes and albuminuria (a urinary
      albumin-to-creatinine ratio (UACR) 200 to 3000 mg/g and an estimated glomerular filtration
      rate (eGFR) ≥30 ml/min/1.73m2). Effects of each TMX-049 dose on UACR will be assessed in
      terms of ratios using log-transformed UACR at Baseline and after a 12-week period of
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes treated with ≥1 glucose-lowering medication for at least 12 months

          -  UACR 200 to 3000 mg/g

          -  eGFR ≥30 ml/min/1.73m2

          -  Treated with at least the minimal recommended dose of an angiotensin converting enzyme
             inhibitor (ACEI) or an angiotensin II receptor blocker (ARB), but not both

        Exclusion Criteria:

          -  History of Type 1 diabetes

          -  Women who are breast feeding

          -  Treatment with any uric acid-lowering therapy within previous 2 weeks

          -  History of intolerance to any XO (xanthine oxidase) inhibitor

          -  History of a gout flare requiring pharmacologic treatment

          -  History or presence of tophaceous gout

          -  History of immunosuppressant treatment for any known or suspected renal disorder

          -  History of a non-diabetic form of renal disease

          -  Glycosylated hemoglobin (HbA1c) >11%

          -  sUA <4.0 mg/dL or >10.0 mg/dL

          -  Positive urinary pregnancy test

          -  Dialysis for acute renal failure within previous 6 months

          -  Renal allograft in place or a scheduled kidney transplant within the next 22 weeks

          -  Congenital or acquired solitary kidney
Academic Stress and Proinflammatory Cytokines: Omega-3 Intervention
Condition: Stress-related Changes in Inflammation
MeSH terms: Inflammation
Intervention: omega-3 supplementation; Oral omega-3 fish oil placebo
Intervention description: 2.5 g/day omega-3; to match experimental dosage
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: affect; inflammation

Summary:

      This study is designed to examine the effects of fish oil on immune function and mood in
      medical students.
    

Eligibility criteria:

        Inclusion Criteria:

          -  OSU preclinical medical or dental student, or graduate nursing student

          -  male or female

        Exclusion Criteria:

          -  taking certain medications with immune or endocrine effects

          -  chronic health conditions

          -  smoking

          -  excessive use of alcohol or caffeine

          -  significant digestive problems

          -  routine use of fish oil or flaxseed supplements or high fish intake

          -  fish allergy
A Study to Evaluate the Long-term Safety and Efficacy of Fenebrutinib in Participants Previously Enrolled in a Fenebrutinib Chronic Spontaneous Urticaria (CSU) Study
Condition: Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Intervention: GDC-0853
Intervention description: Participants were administered GDC-0853 200mg orally, as per the dosing schedules described above.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a Phase II, multicenter, open-label extension (OLE) study to evaluate the long-term
      safety and efficacy of fenebrutinib in participants with Chronic Spontaneous Urticaria (CSU)
      who have completed the treatment period in a fenebrutinib CSU parent study. Participants may
      enroll in this OLE study at any time after completing the treatment period of the parent
      study. Participants will receive open-label fenebrutinib at a dose of 200 milligram (mg)
      orally twice a day. Treatment may continue until the end of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to comply with the study protocol, in the investigator's judgment

          -  Completion of the treatment period as specified in the parent study

          -  Acceptable demonstration of tolerance to study drug during the parent study as
             determined by the investigator or Medical Monitor

          -  For participants receiving treatment with proton-pump inhibitors (PPIs) or H2-receptor
             antagonists (H2RAs), agreement to maintain treatment at a stable dose for the first 12
             weeks of the study

          -  For women of childbearing potential: agreement to remain abstinent (refrain from
             heterosexual intercourse) or use contraceptive measures, and agreement to refrain from
             donating eggs

          -  For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use
             a condom, and agreement to refrain from donating sperm

        Exclusion Criteria

          -  Pregnant or breastfeeding, or intending to become pregnant during the study or within
             4 weeks after the final dose of fenebrutinib

          -  Treatment with any investigational agent or live/attenuated vaccine in the preceding 6
             weeks

          -  Any signs or symptoms of infection judged by the investigator to be clinically
             significant since completing the treatment period of the parent study

          -  Any significant changes (e.g., events, changes in medication) occurring after
             completion of participation in the parent study that, in the investigator's judgment,
             would increase the risk of adverse events in this OLE study
ET 743 (Yondelis) in Men With Advanced Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: ET 743
Intervention description: ET-743 administered IV by 24-hr infusion every 3 weeks
Intervention MeSH terms: Trabectedin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Prostate Cancer; Prostate Cancer; Trabectedin; ET 743; Yondelis

Summary:

      The main purpose of this study is to find out what effects (good or bad) trabectedin (ET743)
      has on men with advanced prostate carcinoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed adenocarcinoma of the prostate

          -  Radiographically documented metastatic disease

          -  Surgical or chemical castration

          -  Prostate specific antigen (PSA) > 5 ng/ml

          -  Castration resistant prostate cancer (CRPC)

          -  One previous taxane-based chemotherapy regimen

          -  Eastern Cooperative Group (ECOG) performance status 0,1 or 2

          -  Neutrophil count > 1,500/ul

          -  Platelet count > 100,000/ul

          -  Serum bilirubin < 1.0 x upper limit normal (ULN)

          -  Serum alkaline phosphatase < 1.5 x ULN

          -  Asparate aminotransferase/Alanine aminotransferase < 2.5 x ULN

          -  Albumin > 2.5 g/dl

          -  Serum creatinine < 1.5 x ULN

          -  Prior hormonal therapy

        Exclusion Criteria:

          -  Chemotherapy treatment within 4 weeks of study entry

          -  Patient not employing adequate contraception

          -  Serious illness or medical conditions, specifically: uncontrolled congestive heart
             failure or history of myocardial infection or active angina pectoris within 6 months;
             active infectious process; chronic active liver disease, including chronic hepatitis
             B, C or cirrhosis

          -  Current anti-cancer treatment with any non-FDA approved investigational drug