bioihbjkbjnl/mcl2 huggingface dataset:
Cathelicidin and Vitamin D: Impact on Populations At-Risk and With COPD
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Intervention: Vitamin D3
Intervention description: Oral supplementation with 50,000 IU vitamin D3 weekly for eight weeks in individuals with reduced vitamin D levels.
Intervention MeSH terms: Vitamin D; Cholecalciferol
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Cathelicidin; Vitamin D

Summary:

      This proposal will evaluate a potential mechanism of increased risk of lung function
      impairment, cathelicidin levels, as well as determine if vitamin D replacement can alter this
      pathway. This study will improve the understanding of factors which can lead to chronic lung
      disease. If effective, this application would also provide the justification to study vitamin
      D as a therapy to improve lung health.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women age 18-65 who are current or former smokers

          -  Serum calcium<10.5mg/dL

          -  25-Hydroxy Vitamin D (OHD)<20 ng/mL

          -  Creatinine Clearance ≥60 mL/min as estimated by the Cockcroft-Gault equation

          -  Women of reproductive potential with negative serum or urine pregnancy test and
             subjects must refrain from participating in a conception process and subject/partner
             must use at least 2 reliable forms of contraceptives for the duration of the study

          -  For participants with COPD, Forced Expiratory Volume in 1 second (FEV1) greater than
             50% predicted.

          -  For smokers, current cigarette use (defined as regularly smoking 5 cigarettes per day)

        Exclusion Criteria:

          -  Current use of vitamin D supplements

          -  Known allergy/sensitivity or any hypersensitivity to components of study drugs or
             their formulations

          -  Pregnancy or currently breast-feeding

          -  History of nephrolithiasis

          -  HIV positive serostatus

          -  Continuous oxygen use >2 liters/min via nasal cannula

          -  Any condition that, in the opinion of the site investigator, would compromise the
             subject's ability to participate in the study.
Efficacy, Safety, and Tolerability of JNJ-27018966 (Eluxadoline) in the Treatment of Irritable Bowel Syndrome With Diarrhea
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Intervention: Eluxadoline; Placebo
Intervention description: Tablets, orally, twice daily.; Matching placebo oral tablets twice daily.
Intervention MeSH terms: Eluxadoline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 807.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Irritable bowel syndrome with diarrhea; Irritable bowel syndrome; Diarrhea predominant irritable bowel syndrome; Colonic diseases; Colonic diseases, functional; Digestive system disease; Gastrointestinal disease; Intestinal disease; Colonic pseudo-obstruction; Diarrhea; Signs and Symptoms, Digestive

Summary:

      The purpose of this study is to determine the efficacy, safety, and tolerability of different
      doses of JNJ-27018966 (eluxadoline) compared with placebo in the treatment of patients with
      irritable bowel syndrome with diarrhea (IBS-d).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Patient has a diagnosis of IBS by Rome III criteria with a subtype of diarrhea

          -  Female patients must be:

          -  postmenopausal, defined as amenorrhea for at least 2 years at Prescreening,

          -  surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation,
             or otherwise be incapable of pregnancy),

          -  abstinent, or

          -  if sexually active, be practicing an effective method of birth control.

        Key Exclusion Criteria:

          -  Patient has a diagnosis of IBS by Rome III criteria with a subtype of constipation,
             mixed IBS, or unsubtyped IBS

          -  Patient has a history of inflammatory or immune-mediated gastrointestinal (GI)
             disorders including inflammatory bowel disease (ie, Crohn's disease, ulcerative
             colitis) and celiac disease

          -  Patient has a history of diverticulitis within 6 months prior to Prescreening

          -  Patient has a history of intestinal obstruction, stricture, toxic megacolon, GI
             perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic
             colitis, impaired intestinal circulation (eg, aortoiliac disease), thrombophlebitis of
             a major vein, or hypercoagulable states.

        Other protocol-specific eligibility criteria may apply.
A Trial of CS-747 (Prasugrel) Compared With Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention (PCI)
Condition: Cardiovascular Diseases; Heart Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases
Intervention: Prasugrel (CS-747); Clopidogrel
Intervention description: Administered orally; Administered orally
Intervention MeSH terms: Clopidogrel; Prasugrel Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 905.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effects of a drug known as CS-747 (also known as
      prasugrel) on subjects having a procedure called a percutaneous coronary intervention (also
      referred to as PCI) in which a doctor will attempt to open a blocked vessel (or vessels) in
      the heart using a catheter (a long thin tube) that has a small balloon on the end. In many
      cases, patients who have this procedure receive a stent, a small wire spring that helps keep
      the vessel open.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be candidates for elective or urgent PCI with intended coronary
             stenting.

          -  Men or non-pregnant women (that is, postmenopausal women, women who are surgically
             sterile, or women of childbearing potential who have a negative urine or serum
             pregnancy test) who are greater than or equal to 18 and less than or equal to 75 years
             of age.

        Exclusion Criteria:

          -  Patients must not have planned PCI procedure as initial treatment for an acute
             ST-elevation acute myocardial infarction (STEMI)

          -  Patients must not be receiving or will receive oral anticoagulation therapy that
             cannot be safely discontinued for the duration of the study

          -  Patients must not have cardiogenic shock or severe congestive heart failure

          -  Patients must not have active internal bleeding or history of bleeding diathesis

          -  Patients must not have prior history of hemorrhagic cerebrovascular accident (CVA) or
             nonhemorrhagic CVA within 2 years of enrollment
A Phase 2 Trial of IW-1973, A Stimulator of Soluble Guanylate Cyclase (sGC), in Patients With Stable Type 2 Diabetes and Hypertension
Condition: Diabetes Mellitus, Type 2; Hypertension
MeSH terms: Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Matching Placebo; IW-1973
Intervention MeSH terms: Praliciguat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 30 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To evaluate the impact of escalating doses of IW-1973 on endothelial function [using EndoPAT
      to measure fingertip small vessel pulse volume], blood pressure (BP), and heart rate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is ambulatory male or female

          -  Patient's body mass index score is >20 and <40 kg/m2 at the Screening Visit

          -  Women of childbearing potential must have a negative pregnancy test at the time of
             check-in and must agree to use double-barrier contraception throughout the duration of
             the study

          -  Patient's health is stable with no clinically significant findings on a physical
             examination

          -  Patient has type 2 (ie adult onset) diabetes mellitus diagnosed by a physician or
             nurse practitioner > 6 months before the Screening Visit, and an entry HbA1c that does
             not mandate prompt intervention for improved control

          -  Patient has hypertension diagnosed by a physician or nurse practitioner > 6 months
             before the Screening Visit and BP within the protocol's acceptable range

          -  Patients must be on a stable regimen for glycemic control, and a stable regimen for
             hypertension control that includes an angiotensin converting enzyme inhibitor (ACEi)
             or angiotensin receptor blocker (ARB)

          -  Patient has abnormal endothelial function measured by the EndoPAT

          -  Other inclusion criteria per protocol

        Exclusion Criteria:

          -  Patient has a clinically significant active or unstable medical condition that, in the
             opinion of the Investigator, would preclude trial participation

          -  Patient is on medication(s) that when co-administered with a soluble guanylate cyclase
             (sGC) stimulator, could increase the risk of hypotension

          -  Patient has evidence of severe or active end-organ damage attributable to diabetes

          -  Patient has severe renal insufficiency, has undergone renal transplantation, or has
             planned renal transplantation

          -  Other exclusion criteria per protocol
Genetically Targeted Therapy for the Prevention of Symptomatic Atrial Fibrillation in Patients With Heart Failure
Condition: Current or Recent History of Atrial Fibrillation
MeSH terms: Heart Failure; Atrial Fibrillation; Atrial Flutter
Intervention: bucindolol hydrochloride; metoprolol succinate; Placebo oral capsule
Intervention MeSH terms: Metoprolol; Bucindolol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 267.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: atrial fibrillation; atrial flutter; heart failure; reduced left ventricle ejection fraction; electrical cardioversion; GENETIC-AF; Medtronic; bucindolol; pharmacogenetic; ARCA; Toprol; Toprol-XL; Metoprolol; Metoprolol succinate

Summary:

      This study is being done to compare the effects of bucindolol hydrochloride (bucindolol) to
      metoprolol succinate (Toprol-XL) on the recurrence of symptomatic atrial fibrillation/atrial
      flutter in patients with heart failure who have a specific genotype for the beta-1 adrenergic
      receptor.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Must weigh at least 40 kg

          -  Possess the β1389 Arg/Arg genotype

          -  Left Ventricular Ejection Fraction (LVEF) < 0.50 assessed within 12 months prior to
             Screening

          -  At least one episode of symptomatic paroxysmal or persistent AF within 180 days of
             Screening

          -  Clinically appropriate for electrical cardioversion (ECV) if AF/AFL is present after
             study drug initiation

          -  Receiving appropriate anticoagulation therapy prior to Randomization

        Key Exclusion Criteria:

          -  NYHA Class IV symptoms at the time of Randomization

          -  Significant fluid overload at Randomization

          -  Permanent AF at Screening

          -  More than two previous ECV within 6 months of Randomization or if the most recent ECV
             failed to produce SR

          -  Presence of an LVAD, or likely to requirement LVAD placement within 6 months of
             Randomization

          -  History of a successful atrioventricular (AV) node ablation

          -  History of an AF/AFL ablation within 30 days of Randomization

          -  Evidence of an appropriate firing of an implanted cardioverter-defibrillator (ICD)
             device for ventricular tachycardia (VT) or ventricular fibrillation (VF) within 90
             days of Randomization
Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
Condition: Nonalcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: Placebo; PF-05221304
Intervention description: Placebo; PF-05221304, Experimental Drug
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: C1171002 is a randomized, double blind, placebo controlled, 5 arm (placebo, plus 4 active doses of PF 05221304), parallel group study.
Masking: Double (Participant, Investigator)
Masking description: Double-Blind
Enrollment: 305.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: PF-05221304; NAFLD; NASH; features of metabolic syndrome; Dose-Ranging Study

Summary:

      Phase 2a, dose-ranging Study with PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body Mass Index >= 25 kg/m2

          -  Body Weight > 50 kg

          -  Liver fat (assessed via MRI-PDFF) >= 8%

          -  Biopsy-proven NASH - diagnosed in previous 24-months

          -  Presumed NASH - per Sponsor's definition

          -  NAFLD with minimal inflammation/fibrosis

          -  Features of Metabolic Syndrome

        Exclusion Criteria:

          -  Alcohol-induced steatohepatitis or other forms of chronic liver disease

          -  Positive for Hepatitis B, Hepatitis C, or Human Deficiency Virus

          -  Severe Renal Impairment

          -  Contraindications for MRI
Effect of BIBW 2948 BS in COPD
Condition: Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic
MeSH terms: Bronchitis; Bronchitis, Chronic; Pulmonary Disease, Chronic Obstructive
Intervention: BIBW 2948 BS; Placebo
Intervention description: Capsule; Capsule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 40 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Study of BIBW 2948 BS in Patients with COPD and Chronic Bronchitis
    

Eligibility criteria:

        Inclusion Criteria:

          -  COPD smokers

          -  ages between 40 and 70

        Exclusion Criteria:

          -  Significant other diseases

          -  abnormal hematology

          -  abnormal liver function

          -  psychiatric disorders

          -  pulmonary obstruction

          -  asthma, allergic rhinitis

          -  dependance on oxygen

          -  patients with history of myocardial infarction

          -  patients with history of cancer

          -  women of child bearing potential

          -  antiplatelet or anticoagulation therapy
Safety and Efficacy of LCI699 in Cushing's Disease Patients
Condition: Cushings Disease; Cushing Disease
MeSH terms: ACTH-Secreting Pituitary Adenoma; Pituitary ACTH Hypersecretion
Intervention: LCI699
Intervention description: Osilodrostat 1 mg and 5 mg capsules, was prepared by Novartis and supplied to the Investigator. The capsule formulation of osilodrostat was later changed to tablets and this change was implemented in the study with Protocol amendment 6. Osilodrostat was open labeled 1 mg, 5 mg, 10 mg and 20 mg tablets.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
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
Keywords: Cushing Disease; osilodrostat; LCI699; Pituitary Gland; Adrenocorticotropic Hormone

Summary:

      This exploratory study is a proof of concept study to determine whether LCI699 can safely
      reduce the level of urinary free cortisol in patients with Cushing's disease.

      In addition, this study evaluated the long term efficacy and safety of LCI699 including an
      additional 12 week of treatment followed by a 12 month long term optional extension.

      A second extension provided patients who were clinically benefitting from LCI699 an
      opportunity to continue to have access to the drug until LCI699 was commercially available
      and reimbursed or through the availability of a local access program.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a confirmed diagnosis of Cushing's Disease (persistent or recurrent) as
             evidenced by increased 24-hour urine free cortisol (UFC), normal or increased morning
             plasma Adrenocorticotropic Hormone (ACTH), and pituitary origin of excess ACTH.

          -  Patients with de novo Cushing's disease can be included only if they are not
             considered candidate for surgery

        Exclusion Criteria:

          -  Patients treated with mitotane 6 months prior to Visit 1

          -  Patients with compression of the optic chiasm

          -  Patients with a known inherited syndrome as the cause for hormone over secretion

          -  Patients with Cushing's syndrome due to ectopic ACTH secretion or adrenal Cushing's
             syndrome

          -  Patients with pseudo-Cushing's syndrome

          -  Patients who are not biochemically euthyroid

          -  Diabetic patients with poorly controlled diabetes (HbA1c >9%)

          -  Women of child-bearing potential, defined as all women physiologically capable of
             becoming pregnant, unless they are using highly effective methods of contraception
             during dosing and for 1 week after completion of dosing.

          -  Patients who have received pituitary irradiation within five years prior to Visit 1.

          -  Patients with risk factors for QTc prolongation or Torsade de Pointes.
Study Evaluating the Effect of IMA-638 in Subjects With Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: IMA-638; IMA-638; placebo
Intervention description: SC Injection, 12 weeks; SC Injection, 12 weeks; placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 159.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Primary purpose is to assess if IMA-638 is safe and improves asthma in subjects with
      persistent asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Generally healthy men and women with persistent asthma, 18 to 70 years of age, with
             body weight between 50 kg and 115 kg.

          -  History of treatment with a medium to high dose of inhaled corticosteroids (ICS), with
             or without long-acting beta-agonists (LABA), for at least 2 months prior to the
             screening visit and must remain constant during the study.

          -  FEV1 ≥ 55% to ≤ 80% predicted and demonstrated improvement in FEV1 (L) with inhaled
             albuterol (salbutamol) (reversibility) of ≥ 12%.

        Exclusion Criteria:
Implications for Treatment of the Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Intervention: atorvastatin; placebo
Intervention description: 40 m.g. o.d. tablets for 6 months; Placebo
Intervention MeSH terms: Atorvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: metabolic syndrome; Volunteers recruited from the community

Summary:

      To characterize features of metabolic syndrome in volunteers. To undertake a randomised trial
      to determine whether treatment with a statin improves muscle microvascular blood flow.
    

Eligibility criteria:

        Inclusion criteria Body mass index (BMI) 20-35 kg/m^2" and "> 3 criteria for the metabolic
        syndrome (NCEP III ATP criteria - see below) , one of which will be hypertriglyceridaemia,
        i.e. fasting plasma triglycerides >2.0 mmol/L - a cardinal lipid abnormality of the
        syndrome

        NCEP III ATP metabolic syndrome criteria are:

        Waist greater than or equal to 102 cm BP greater than 130 / 85 mmHg TG greater than or
        equal to 1.7mmol/l Glucose greater than or equal to 6.1 mmol/l HDL less than 1.0 mmol/l

        Exclusion Criteria:

        Aged <18 years Aged >75 years Known diabetes; renal, liver, or uncontrolled thyroid
        disease; uncontrolled hypertension; treatment with lipid-modifying drugs; antihypertensive
        medication; corticosteroid therapy; or hormone replacement therapy.