bioihbjkbjnl/mcl2 huggingface dataset:
A Clinical Pharmacological Study of Rabeprazole Sodium in Japanese Healthy Adult Male Volunteers (Study E3810)
Condition: Healthy
Intervention: Rabeprazole sodium, 5 mg Tablets; Rabeprazole sodium, 10 mg Tablets; Rabeprazole sodium, 20 mg Tablets; Rabeprazole sodium, 40 mg Tablets (two 20 mg Tablets)
Intervention description: Rabeprazole sodium Tablets, 5 mg administered for 5 days.
Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer.
Day 2 to Day 4: participants received a single dose with 200 mL of water >= 2 hours after the completion of breakfast.; Rabeprazole sodium Tablets, 10 mg administered for 5 days.
Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer.
Day 2 to Day 4: participants received a single dose with 200 mL of water >= 2 hours after the completion of breakfast.; Rabeprazole sodium Tablets, 20 mg administered for 5 days.
Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer.
Day 2 to Day 4: participants received a single dose with 200 mL of water >= 2 hours after the completion of breakfast.; Rabeprazole sodium Tablets, 40 mg (two 20 mg Tablets) administered for 5 days.
Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer.
Day 2 to Day 4: participants received a single dose with 200 mL of water, >=2 hours after the completion of breakfast.
Intervention MeSH terms: Rabeprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: Male
Minimum age: 20 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Rabeprazole; proton pump inhibitor; pharmacokinetics; pharmacodynamics; healthy adult male Japanese subjects

Summary:

      The purpose of this study is to compare the pharmacodynamics/pharmacokinetics of 5 mg, 10 mg,
      20 mg and 40 mg of Rabeprazole sodium (E3810) when administered repeatedly once daily for 5
      days to healthy adult male Japanese participants. This was a single-center, open-label,
      randomized, four-treatment, four-way crossover study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy adult Japanese male between the age of 20-40

          -  body mass index between 18.5-25

        Exclusion Criteria:

          -  clinically significant abnormal physical examination, vital signs or electrocardiogram

          -  use of any prescription medication, antacid, nutritional supplement, vitamin
             preparation, or herb-containing drug within the previous 4 weeks

          -  use of any non-prescription medication within the previous 1 week

          -  history of drug or alcohol abuse
A Study of ALN-PCSSC in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
Condition: Homozygous Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Homozygous Familial Hypercholesterolemia; Hypercholesterolemia
Intervention: ALN-PCSSC; Standard of Care
Intervention description: ALN-PCSSC is a small interfering ribonucleic acid (siRNA) that inhibits PCSK9 synthesis and is given as SC injections.; Included maximally-tolerated statin therapy and/or other low density lipoprotein-cholesterol (LDL-C)-lowering therapies.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety, tolerability, and efficacy of ALN-PCSSC in
      participants with homozygous familial hypercholesterolemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females, ≥12 years of age with a diagnosis of homozygous familial
             hypercholesterolemia by genetic confirmation or a clinical diagnosis based on a
             history of an untreated low-density lipoprotein cholesterol (LDL-C) concentration >500
             mg/deciliter (dL) [13 millimoles/liter (mmol/L)] together with either xanthoma before
             10 years of age or evidence of heterozygous familial hypercholesterolemia in both
             parents.

          -  Stable on a low-fat diet.

          -  Stable on pre-existing, lipid-lowering therapies (such as statins,
             cholesterolabsorption inhibitors, bile-acid sequestrants, or combinations thereof) for
             at least 4 weeks with no planned medication or dose change for the duration of study
             participation.

          -  Fasting central lab LDL-C concentration >130 mg/dL (3.4 mmol/L) and triglyceride
             concentration <400 mg/dL (4.5 mmol/L).

          -  Body weight of 40 kilograms (kg) or greater at screening.

        Exclusion Criteria:

          -  LDL or plasma apheresis within 8 weeks prior to the screening visit, and no plan to
             receive it during the study because of the attendant difficulty in maintaining stable
             concentrations of LDL-C while receiving apheresis.

          -  Use of mipomersen or lomitapide therapy within 5 months of screening.

          -  Previous treatment with monoclonal antibodies directed towards PCSK9 within 8 weeks of
             screening.

        The above information is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
Safety and Efficacy of AVP-923 in the Treatment of Levodopa-induced Dyskinesia in Parkinson's Disease Patients
Condition: Dyskinesia; Parkinson's Disease
MeSH terms: Parkinson Disease; Dyskinesias
Intervention: AVP-923-45; Placebo
Intervention description: One capsule twice daily for 14 days; One capsule twice daily for 14 days
Intervention MeSH terms: Quinidine; Dextromethorphan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 14.0
Sex: All
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: levodopa; dyskinesia; parkinson's disease; AVP-923; dextromethorphan; quinidine

Summary:

      To evaluate the efficacy, safety, and tolerability of AVP-923 capsules containing 45 mg
      dextromethorphan and 10 mg quinidine (AVP-923-45) compared to placebo for the treatment of
      levodopa-induced dyskinesia (LID) in patients with Parkinson's disease (PD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females 30 to 80 years of age, inclusive.

          -  Diagnosis of idiopathic PD meeting the United Kingdom Parkinson's disease Society
             Brain Bank criteria.

          -  Levodopa-induced dyskinesia present greater than 25% of the day as per MDS-UPDRS.

          -  Dyskinesia of at least moderate severity as per MDS-UPDRS

          -  Amantadine and Monoamine Oxidase (MAO) inhibitors must be discontinued at least three
             weeks prior to randomization.

          -  Subjects currently receiving anti-parkinsonian medications, including all Levodopa
             preparations are eligible provided they have been on a stable dose of these
             medications for at least 1 month prior to randomization.

          -  Concomitant use of antidepressants such as selective serotonin reuptake inhibitors are
             allowed, provided the dose has been stable for at least 1 month prior to
             randomization.

        Exclusion Criteria:

          -  Subject had a prior surgery for PD except Deep Brain Stimulation (Deep Brain
             Stimulation must not have been performed within one year of screening)

          -  Hoehn and Yahr score of 5 when "off".

          -  Subject with Cognitive impairment and/or history of psychiatric manifestations or
             active hallucinations.

          -  Subjects with any history of complete heart block, QTc prolongation, or torsades de
             pointes.

          -  Subjects with any family history of congenital QT interval prolongation syndrome.

          -  Subjects with history of postural syncope, or any history of unexplained syncope
             within the last 12 months.

          -  Subjects with a history of substance and/or alcohol abuse within the past 2 years.
Efficacy of LCQ908 on Cardiovascular Risk
Condition: Coronary Artery Disease; Hypertriglyceridemia
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Hypertriglyceridemia
Intervention: pradigastat (LCQ908); Placebo
Intervention description: pradigastat tablets were supplied to the investigators at dose strengths of 10 mg and 20 mg as individual patient packs.; matching placebo tablets
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 41.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: coronary artery disease,; LCQ908,; hyperlipidemia,; hypertriglyceridemia,; pradigastat

Summary:

      This is a study designed to evaluate the potential for the pradigastat (LCQ908) to impact
      cardiovascular risk.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of coronary artery disease

          -  Elevated triglycerides

          -  On medication to help lower cholesterol

        Exclusion Criteria:

          -  Poorly controlled diabetic patients and/or change in diabetic medication within 12
             weeks of screening

          -  History of myocardial infarction (heart attack) within 6 months of screening

          -  History of a procedure to open a blocked coronary artery within 12 months of
             enrollment

          -  History of Coronary Artery Bypass Graft (CABG) surgery

          -  History of congestive heart failure

          -  History of significant heart valve disease
Fermented Milk Drink on Human Intestinal Microflora
Condition: Signs and Symptoms, Digestive
MeSH terms: Signs and Symptoms, Digestive
Intervention: Yakult®300; Lactobacillus casei strain Shirota
Intervention description: Yakult®300 was given 100 ml once per day for four weeks.
Fermented or unfermented milk per 100 ml bottle per day for four week.; Lactobacillus casei strain Shirota
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Probiotics; Lactobacillus; Intestine; Flora

Summary:

      Fermented milk is a popular drink. Recent studies revealed that some fermented milk
      containing some strains of lactic acid bacteria have health-promoting effects through
      improvement of the intestinal microflora and modulation of the immune system. Lactobacillus
      casei strain Shirota (LcS) is a probiotic bacterium used in the production of fermented milk
      products and lactic acid bacteria preparations. LcS has been shown to modify allergen-induced
      immune responses in allergic rhinitis, altering fermentation patterns in the small bowel,
      prevention of recurrent urinary tract infections in women. Yakult®300 is a fermented milk
      containing at least 3x10^10 live LcS cells per 100 ml bottle. This study aimed to evaluate
      the effects of a fermented milk drink containing Lactobacillus casei strain Shirota on the
      human intestinal microflora.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adult volunteers and willing to give voluntary written informed consent

        Exclusion Criteria:

          -  Major systemic disease

          -  Pregnancy, parturient and feeding woman, or expect to be pregnant

          -  Abnormal liver function

          -  Abnormal renal function

          -  Abnormal gastrointestinal function

          -  Take medication for gastrointestinal function

          -  Stroke, myocardial infarction,

          -  Poor compliance for study protocol
HEROIC (Heparin Requirement in Counterpulsation)
Condition: Cardiogenic Shock
MeSH terms: Shock, Cardiogenic
Intervention: Heparin; Without Heparin
Intervention description: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP).; Intra-Aortic balloon Pump (IABP) without Heparin.
Intervention MeSH terms: Heparin; Calcium heparin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Intraaortic balloon pumping; Heparin; Limb ischemia; Bleeding

Summary:

      Patients with intra-aortic balloon pumps (catheters placed in the groin connected to a pump
      which assists the heart by opening and closing a balloon in the aorta, thereby decreasing the
      work of the heart and improving blood flow to the coronary arteries) often receive
      intravenous (IV) heparin (a "blood thinner") to prevent circulation problems in the leg
      (where they are inserted). When intra-aortic balloon pumps were initially developed, the
      catheters were larger than the catheters used today. Due to the large size of the catheter
      and the material used to make the catheter, it was thought that intravenous heparin would
      prevent poor blood flow to the leg that contained the temporary catheter. Intravenous
      heparin, however, has never been proven to maintain good blood flow in these patients. The
      catheters used with intra-aortic balloon pumps are now smaller in size and made of a material
      that is less likely to produce blood clots. It is not clear that heparin is needed with
      intra-aortic balloon pumps. Bleeding complications associated with intra-aortic balloon pumps
      may be decreased if heparin is not used. In 2004, 99 patients received intra-aortic balloon
      pumps in the cardiac catheterization labs at William Beaumont Hospital. These patients
      received intravenous heparin and experienced a large number of bleeding complications (27
      patients required a blood transfusion). This study will help the investigators to clarify if
      heparin should or should not be routinely used in patients with intra-aortic balloon pumps.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >/= 18 years

          -  Able to provide consent

          -  Insertion of Intra-aortic Balloon Pump (IABP) in William Beaumont Hospital (WBH) cath
             lab

          -  Anticipated duration of IABP >/= 18 hours

        Exclusion Criteria:

          -  Contraindications to heparin

          -  Pre-existing condition requiring heparin administration (other than IABP)

          -  IABP placed outside of the WBH cardiac catheterization lab prophylactically for
             high-risk percutaneous coronary intervention (PCI), without complications)

          -  Pregnant women
Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis
Condition: PBC; Primary Biliary Cirrhosis
MeSH terms: Liver Cirrhosis; Liver Cirrhosis, Biliary; Fibrosis
Intervention: LUM001; Placebo; Ursodeoxycholic Acid
Intervention MeSH terms: Ursodeoxycholic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: PBC

Summary:

      The study is a randomized, double-blind, placebo-controlled, multicenter study. It is a
      13-week Phase 2 study in adults with primary biliary cirrhosis designed to compare the effect
      of daily dosing with UDCA in combination with LUM001 or placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of Primary Biliary Cirrhosis

          2. Moderate to severe pruritus

          3. Taking ursodeoxycholic acid (UDCA) for at least 6 months, or unable to tolerate UDCA

          4. Ability to understand and willingness to sign informed consent prior to initiation of
             any study procedures

        Exclusion Criteria:

          1. History or presence of other concomitant significant liver disease

          2. Liver transplant

          3. Known HIV infection

          4. Women who are pregnant or lactating
Trial of Adjuvant Sutent for Patients With High Risk Urothelial Carcinoma After Neoadjuvant Chemotherapy and Cystectomy
Condition: Urothelial Carcinoma; Bladder Cancer
MeSH terms: Carcinoma; Carcinoma, Transitional Cell
Intervention: Sunitinib
Intervention description: Sunitinib 37.5 mg daily X 16 weeks
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: sunitinib; bladder neoplasm; adjuvant treatment; disease free survival; cystectomy

Summary:

      The purpose of this study is to determine whether sutent (sunitinib)is effective in
      preventing tumor recurrence in patients with high risk bladder cancer who have previously had
      chemotherapy and cystectomy (bladder removal).

      A 4 month supply of the drug is given to patients beginning 2-3 months after bladder removal.
      The patients are followed up to 2 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic diagnosis of bladder carcinoma (>50% urothelial carcinoma)

          -  Prior treatment with at least one cycle of platin-based neoadjuvant chemotherapy

          -  Prior treatment with radical cystectomy revealing pT3NxM0 or pTanyN+M0

          -  ECOG performance status of 0-1 (Appendix 2).

          -  No evidence of metastases within 4 weeks of registration

          -  Adequate organ and marrow function obtained within 14 days of registration

        Exclusion Criteria:

          -  Severe or uncontrolled acute or chronic medical or psychiatric condition

          -  Prior antiangiogenic therapy

          -  Prior pelvic radiation for bladder cancer
Effort to Prevent Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa in Mechanically Ventilated Subjects
Condition: Pseudomonas Aeruginosa
MeSH terms: Pneumonia; Pseudomonas Infections; Healthcare-Associated Pneumonia
Intervention: MEDI3902; Placebo
Intervention description: Participants will receive a single IV dose of MEDI3902 500 mg and 1500 mg in MEDI3902 500 mg arm and MEDI3902 1500 mg arm, respectively.; Participants will receive a single IV dose of placebo matched to MEDI3902.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 188.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Pseudomonas aeruginosa, Pneumonia

Summary:

      Clinical trial looking to evaluate the efficacy and safety of MEDI3902 in mechanically
      ventilated participants for the prevention of nosocomial pneumonia caused by Pseudomonas
      aeruginosa.
    

Eligibility criteria:

        Inclusion Criteria:

        Colonized with P aeruginosa, expected to require prolonged intubation and mechanical
        ventilation, without any evidence of active pneumonia.

        Exclusion Criteria:

        P aeruginosa disease at randomisation; lung injury score consistent with pneumonia; current
        lung disease; currently receiving protocol-specified Anti-P aeruginosa antibiotics,
        moribund participants.
Docetaxel Plus Imatinib Mesylate in Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Imatinib; Docetaxel
Intervention description: Imatinib; Docetaxel
Intervention MeSH terms: Docetaxel; Imatinib Mesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer

Summary:

      This trial evaluates the novel combination of docetaxel with imatinib as first or second line
      therapy in advanced breast cancer with the aim of achieving higher effectiveness and
      potentially reducing side effects.
    

Eligibility criteria:

        Inclusion Criteria:

        To be included in this study, you must meet the following criteria:

          -  Metastatic breast cancer confirmed by biopsy

          -  No more than one prior chemotherapy regimen for metastatic breast cancer

          -  Able to perform activities of daily living with minimal assistance

          -  Adequate bone marrow, liver and kidney function

          -  Age 18 years or older

          -  Give written informed consent

        Exclusion Criteria:

        You cannot participate in this study if any of the following apply to you:

          -  Moderate to severe peripheral neuropathy

          -  Uncontrolled blood pressure or uncontrolled heart beat irregularities

          -  Diabetes Mellitus with fasting blood sugar greater than 200 mg %

          -  Significant heart disease within the prior 6 months

          -  Severe or uncontrolled medical disease

          -  Active uncontrolled infection

          -  Known chronic liver disease

          -  Known diagnosis of HIV infection

          -  Pregnant or breast feeding females

        Please note: There are additional inclusion/exclusion criteria. The study center will
        determine if you meet all of the criteria. If you do not qualify for the trial, study
        personnel will explain the reasons. If you do qualify, study personnel will explain the
        trial in detail and answer any questions you may have.