bioihbjkbjnl/mcl2 huggingface dataset:
Cilostazol for HFpEF
Condition: Heart Failure With Preserved Ejection Fraction
MeSH terms: Heart Failure
Intervention: Cilostazol 100Mg Tab; Placebo
Intervention description: Cilostazol Twice a Day; Placebo
Intervention MeSH terms: Cilostazol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: n-of-1 design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Determine if cilostazol improves symptoms and NTproBNP levels (heart failure blood marker) in
      heart failure with preserved ejection fraction (HFpEF) - a prevalent syndrome without
      targeted evidence-based treatment.

      This will be assessed in a prospective 1-month single blinded study with 2 cross-overs n-of-1
      study design with placebo and cilostazol
    

Eligibility criteria:

        Inclusion Criteria:

          -  >18 yrs

          -  LVEF ≥ 50% (on last assessment, <2 years)

          -  Diagnosis of HFpEF or Shortness of breath with NYHA Class ≥ 2 and one of the
             following:

               1. pulmonary edema on chest imaging or documented on exam or on loop diuretics

               2. NTproBNP >400 ng/ml in the last 24 months

               3. HFpEF>50% hospitalization in the last 3 years

               4. Qualitative echo: > mild diastolic dysfunction on echo report and > mild left
                  ventricular hypertrophy and left atrial dilation or quantitative echo: left
                  ventricular hypertrophy [men ≥115 g/m², women ≥95 g/m² or relative wall thickness
                  >0.42 or any LV wall thickness >1.2cm and has LA dilation (>28ml/m2)

        Exclusion Criteria:

          -  <18yo

          -  resting heart rate >100/min

          -  patients with LVEF <50%

          -  advanced end-stage heart failure,

          -  symptomatic COPD on home O2,

          -  uncontrolled severe HTN (SBP >160/100 mmHg)

          -  patients with life expectancy <6 months,

          -  end-stage liver cirrhosis,

          -  more than moderate valve disease,

          -  infiltrative myocardial disease

          -  constrictive pericarditis or myocarditis,

          -  patients unable to participate in follow up,

          -  pregnant patients or patients without reliable contraceptive agent for the duration of
             study participation),

          -  left ventricular outflow tract obstruction,

          -  bleeding dyscrasias, blood dyscrasias,

          -  Patients on oral ketoconazole, itraconazole, fluconazole, miconazole, fluvoxamine,
             fluoxetine, nefazodone, sertraline, erythromycin, clarithromycin or azithromycin
Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer
Condition: Neoplasms, Breast
MeSH terms: Breast Neoplasms; Neoplasm Metastasis; Brain Neoplasms
Intervention: lapatinib
Intervention description: tyrosine kinase inhibitor
Intervention MeSH terms: Lapatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 242.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: breast cancer; brain metastases; ErbB2 positive; HER2 positive; neoplasms; cancer; lapatinib; LAP016A2202; LAP016A; CLAP016A2202; GW572016

Summary:

      Determine how safe and effective lapatinib is when used to treat patients with ErbB2
      overexpressing breast cancer that has spread to the brain and is still progressing there even
      after radiation treatment using WBRT (whole brain radiotherapy) or SRS (stereotactic
      radiosurgery) to the brain. Lapatinib is an oral drug that will be taken every day. Tests for
      safety and efficacy will be performed every 4 weeks or 8 weeks (depending on the test) during
      the course of the study.
    

Eligibility criteria:

        Inclusion criteria:

          -  Signed Informed Consent

          -  ErbB2(HER2)overexpressing breast cancer.

          -  Brain lesion(s) which are progressing.

          -  Prior treatment of brain metastases with Whole Brain Radiotherapy (WBR)and/or
             Stereotactic Radiosurgery (SRS).

          -  Prior treatment with trastuzumab (Herceptin), either alone or in combination with
             chemotherapy.

          -  Cardiac ejection fraction(LVEF)within the institutional range of normal as measured by
             Echocardiogram.

          -  Able to swallow an oral medication.

          -  Adequate kidney and liver function.

          -  Adequate bone marrow function.

        Exclusion criteria:

          -  Pregnant or lactating females.

          -  Conditions that would effect the absorption of an oral drug.

          -  History of immediate or delayed hypersensitivity reaction to gadolinium contrast
             agents.

          -  Pre-existing severe cerebral vascular disease, such as stroke involving a major
             vessel.

          -  Serious medical or psychiatric disorder that would interfere with the patient's safety
             or informed consent.
Study of Anastrozole +/- AZD8931 in Postmenopausal Women With Endocrine Therapy Naive Breast Cancer
Condition: Neoplasms; Breast Neoplasms; Breast Cancer
MeSH terms: Breast Neoplasms; Neoplasms
Intervention: AZD8931; anastrozole; Placebo
Intervention description: Tablet, oral, bd; Tablet, oral, od; Tablet, oral
Intervention MeSH terms: Anastrozole
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: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer; tumour; breast cancer; metastatic; secondary; locally advanced

Summary:

      The main purpose of this study is to compare progression free survival in patients treated
      with AZD8931 given in combination with anastrozole versus anastrozole alone. The secondary
      objective is to investigate the safety and tolerability of AZD8931 given in combination with
      anastrozole.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients that have locally advanced or metastatic breast cancer. Lesions should not be
             amenable to surgery or radiation of curative intent

          -  Hormone therapy-naive

          -  Estimated life expectancy of more than 12 weeks

        Exclusion Criteria:

          -  Last dose of prior anti-cancer therapy received within 14 days (or longer if required)

          -  Any eye injury or corneal surgery within 3 months prior to receiving first dose of
             study drug.

          -  Currently receiving (and unwilling to discontinue) oestrogen replacement therapy.
             (last dose <7 days prior to randomisation)
Probiotic Prophylaxis of Hirschprung's Disease Associated Enterocolitis (HAEC)
Condition: Hirschsprung Disease
MeSH terms: Enterocolitis; Hirschsprung Disease
Intervention: VSL#3; Placebo
Intervention description: Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (360 billion bacteria or 4 sachets) of VSL#3 will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (180 billion bacteria or 2 sachets) daily in the same amount of formula or breast milk.
E.2.6. Time of start of probiotics: Probiotic vs. placebo will begin once the infant has reached full oral feeding.; Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 62.0
Sex: All
Minimum age: 1 Month
Maximum age: 12 Months
Healthy volunteers: No
Keywords: Hirschsprung disease; enterocolitis; probiotics

Summary:

      Prospective, randomized, controlled trial to test if post-operative administration of
      probiotics in HD patients will lead to a reduction in the occurrence of HAEC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients eligible for enrollment will include all pediatric patients suffering from HD
             at an age of 12 months or younger. All patients will require consent by either parent
             or adult guardian

        Exclusion Criteria:

          -  Patients will be excluded if children that are deemed hemodynamically unstable and
             require immediate operative intervention, age more than one year of age, as this may
             mean very delay in diagnosis and may affect the study results, or infants having major
             congenital anomalies with short life expectancy. Additional exclusion criteria are
             those patients' parents or adult guardian who refuse to undergo randomization.
             Finally, those children who are transferred to another non-participating hospital will
             be excluded.
PT001 MDI Versus Atrovent Study in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: PT001 MDI; Ipratropium Bromide HFA Inhalation Aerosol; Placebo MDI
Intervention description: PT001 MDI administered as two puffs BID for 7 days; Taken as 2 inhalations of the 17 µg per actuation strength MDI QID; Matching placebo to PT001 MDI administered as two puffs BID for 7 days
Intervention MeSH terms: Bromides; Ipratropium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 103.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      The overall objective of this study is to determine an optimal dose and dosing regimen of
      PT001 MDI for further evaluation in later stage studies.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Signed written informed consent

          -  40 - 80 years of age

          -  Clinical history of COPD with airflow limitation that is not fully reversible

          -  Females of non-child bearing potential or females of child bearing potential with
             negative pregnancy test; and acceptable contraceptive methods

          -  Current/former smokers with at least a 10 pack-year history of cigarette smoking

          -  A measured post- bronchodilator FEV1/FVC ratio of < or = 0.70

          -  A measured post- bronchodilator FEV1 > or = 750ml or 30% predicted and < or = 80% of
             predicted normal values

          -  Able to change COPD treatment as required by protocol

        Key Exclusion Criteria:

          -  Women who are pregnant or lactating

          -  Primary diagnosis of asthma

          -  Alpha-1 antitrypsin deficiency as the cause of COPD

          -  Active pulmonary diseases

          -  Prior lung volume reduction surgery

          -  Abnormal chest X-ray (or CT scan) not due to the presence of COPD

          -  Hospitalized due to poorly controlled COPD within 3 months of Screening

          -  Clinically significant medical conditions that preclude participation in the study
             (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma,
             symptomatic prostatic hypertrophy)

          -  Cancer that has not been in complete remission for at least 5 years

          -  Treatment with investigational study drug or participation in another clinical trial
             or study within the last 30 days or 5 half lives

        Other inclusion/exclusion criteria as defined in the protocol
PT003 MDI Dose Confirmation Study
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: PT003; PT001; PT005
Intervention description: PT003 MDI administered as two puffs BID for 7 days; PT001 MDI administered as two puffs BID for 7 days; PT005 MDI administered as two puffs BID for 7 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 185.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      The primary objective of this study is to demonstrate efficacy of PT003 MDI relative to its
      individual components (PT001 MDI and PT005 MDI) in patients with moderate to severe chronic
      obstructive pulmonary disease (COPD).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Signed written informed consent

          -  40 - 80 years of age

          -  Clinical history of COPD with airflow limitation that is not fully reversible

          -  Females of non-child bearing potential or females of child bearing potential with
             negative pregnancy test; and acceptable contraceptive methods

          -  Current/former smokers with at least a 10 pack-year history of cigarette smoking

          -  A measured post- bronchodilator FEV1/FVC ratio of < or = 0.70

          -  A measured post- bronchodilator FEV1 > or = 750ml or 30% predicted and < or = 80% of
             predicted normal values

          -  Able to change COPD treatment as required by protocol

        Key Exclusion Criteria:

          -  Women who are pregnant or lactating

          -  Primary diagnosis of asthma

          -  Alpha-1 antitrypsin deficiency as the cause of COPD

          -  Active pulmonary diseases

          -  Prior lung volume reduction surgery

          -  Abnormal chest X-ray (or CT scan) not due to the presence of COPD

          -  Hospitalized due to poorly controlled COPD within 3 months of Screening

          -  Clinically significant medical conditions that preclude participation in the study
             (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma,
             symptomatic prostatic hypertrophy)

          -  Cancer that has not been in complete remission for at least 5 years

          -  Treatment with investigational study drug or participation in another clinical trial
             or study within the last 30 days or 5 half lives

        Other inclusion/exclusion criteria as defined in the protocol
Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Ofatumumab; Matching placebo of ofatumumab
Intervention description: Provided in pre-filled syringes for subcutaneous injection (s.c.) administration containing 20 mg ofatumumab (50 mg/mL, 0.4 mL content); Matching placebo in pre-filled syringes
Intervention MeSH terms: Ofatumumab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: double-blind; placebo controlled; ofatumumab; relapsing multiple sclerosis; Japanese patients; MS; RMS; adult; OMB157

Summary:

      The study provided efficacy, safety, and pharmacokinetics (PK) data for patients with
      relapsing multiple sclerosis (RMS) in Japan and the other countries
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of multiple sclerosis (MS)

          -  Relapsing MS (RMS)

          -  At least 1 appearance of a new neurological abnormality or worsening of pre-existing
             neurological abnormality during the previous 2 years prior to Screening AND an MRI
             activity (Gd-enhancing T1 lesions or new or enlarging T2 lesions) in brain during the
             previous 1 year prior to randomization

          -  EDSS score of 0 to 5.5

        Exclusion Criteria:

          -  Primary progressive MS or SPMS without disease activity

          -  Patients with an active chronic disease of the immune system other than MS

          -  Patients at risk of developing or having reactivation of hepatitis

          -  Patients with active systemic infections or with neurological findings consistent with
             PML
BMS - Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Dapagliflozin in Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Dapagliflozin; Placebo matching Dapagliflozin
Intervention description: Tablets, Oral, 1 mg, Once daily, 14 days; Tablets, Oral, 0 mg, Once daily, 14 days
Intervention MeSH terms: Dapagliflozin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 171.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To obtain safety and tolerability information in patients with type 1 diabetes where
      Dapagliflozin is added on to Insulin (for 14 days)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 1 diabetes with central lab Glycosylated hemoglobin (A1C) ≥ 7.0% and ≤ 10.0%

          -  Insulin use for at least 12 months and initiation immediately after diagnosis of
             diabetes

          -  Method of Insulin administration [multiple daily injections (MDI) or continuous
             subcutaneous Insulin infusion (CSII)] stable ≥ 3 months

          -  Stable basal Insulin dose ≥ 2 weeks

          -  Ages 18 to 65 years

          -  Central laboratory C-peptide value of < 0.7 ng/mL

          -  Body mass index (BMI) 18.5 to 35.0 kg/m2

        Exclusion Criteria:

          -  History of type 2 diabetes mellitus (T2DM), maturity onset diabetes of young (MODY),
             pancreatic surgery or chronic pancreatitis

          -  Oral hypoglycemic agents

          -  History of diabetes ketoacidosis (DKA) within 24 weeks

          -  History of hospital admission for glycemic control within 6 months

          -  Frequent episodes of hypoglycemia (2 unexplained within 3 months) or hypoglycemic
             unawareness

          -  Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) or Serum total
             bilirubin > 2X Upper limit of normal (ULN)

          -  Abnormal Free T4 [if screening Thyroid Stimulating Hormone (TSH) abnormal]

          -  Estimated glomerular filtration rate (eGFR) Modification of Diet in Renal Disease
             (MDRD) formula ≤ 60 mL/min/1.73m2

          -  Cardiovascular (CV)/Vascular Diseases within 6 months
Study to Determine Optimum Intravenous Starting Dose of MIRCERA for Treatment of Pediatric Participants With Anemia and Chronic Kidney Disease on Hemodialysis
Condition: Renal Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Intervention: Methoxy Polyethylene Glycol-Epoetin Beta
Intervention description: Will be administered IV, every 4 weeks.
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This sequential study will assess the efficacy and safety of multiple doses of intravenous
      (IV) methoxy polyethylene glycol-epoetin beta (MIRCERA), and will determine the optimum
      starting dose for maintenance treatment of anemia in children with chronic kidney disease on
      hemodialysis. Pediatric participants will remain on epoetin alfa, epoetin beta or darbepoetin
      alfa during the screening period, after which they will receive IV MIRCERA monthly, at a
      starting dose related to the previous weekly epoetin or darbepoetin alfa dose. Depending on
      the response achieved, another group may be selected to receive a higher or a lower dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children aged 5-17 years (in Russia only: 12-17 years) with clinically stable chronic
             renal anemia

          -  Hemodialysis for greater than or equal to (>=) 8 weeks

          -  Intravenous stable maintenance treatment with epoetin alfa, epoetin beta, or
             darbepoetin alfa for >= 8 weeks before screening and with no weekly dose change >= 25
             percent (%) (increase or decrease) during the 2 weeks of screening

        Exclusion Criteria:

          -  Overt gastrointestinal bleeding within 8 weeks before screening or during the
             screening period

          -  Red blood cell (RBC) transfusions within 8 weeks before screening or during the
             screening period

          -  Active malignant disease

          -  Pure red cell aplasia (PRCA) or history of PRCA

          -  Pregnant or lactating females

          -  Sexually active participants: not willing to use reliable contraception during
             treatment and for 90 days following the end of treatment