bioihbjkbjnl/mcl2 huggingface dataset:
Extension Study of Zemaira® i.v. Administration in Subjects With Emphysema Due to alpha1-proteinase Inhibitor Deficiency.
Condition: Emphysema; Alpha 1-proteinase Inhibitor Deficiency
MeSH terms: Alpha 1-Antitrypsin Deficiency; Pulmonary Emphysema; Emphysema
Intervention: Alpha1- proteinase inhibitor [human]
Intervention description: Lyophilized preparation of 60 mg/kg body weight intravenously once per week
Intervention MeSH terms: Protease Inhibitors; Alpha 1-Antitrypsin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Alpha1-proteinase inhibitor deficiency; Chronic augmentation and maintenance therapy; Emphysema; Emphysema due to Alpha 1-proteinase inhibitor deficiency

Summary:

      This study is a continuation of the placebo-controlled study CE1226_4001 (NCT00261833) to
      evaluate the efficacy and safety of Zemaira® intravenous (i.v). administration in subjects
      with emphysema due to alpha1-proteinase inhibitor deficiency. The long-term verification of a
      disease-modifying benefit of Zemaira® on the progression of emphysema will be assessed by
      volume-adjusted lung density, measured yearly by computed tomography (CT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who have completed the 2-year treatment and observation period in the Phase
             3/4 Zemaira® CE1226_4001 study (NCT00261833) and are willing to sign informed consent

          -  Males, and non-pregnant, non-lactating females, whose screening pregnancy test is
             negative and who are using contraceptive methods deemed reliable by the investigator

        Exclusion Criteria:

          -  Individuals residing in the US

          -  Current evidence of alcohol abuse or abuse of drugs such as barbiturates,
             benzodiazepines, amphetamines, cocaine, opioids, and cannabinoids

          -  History of allergy, anaphylactic reaction, or severe systemic response to human plasma
             derived products, or known mannitol hypersensitivity, or history of prior adverse
             reaction to mannitol

          -  Current tobacco smoker (smoking must be discontinued for at least 6 months prior to
             study participation)

          -  Conditions or behaviors that interfere with attending scheduled study visits in the
             opinion of the investigator

          -  History of non-compliance

          -  Administration of any other experimental new drug or participation in an investigation
             of a marketed product

          -  Inability to perform necessary study procedures
Follow up Study of Patients on Fingolimod Who Were Enrolled in the Original Biobank Study (CFTY720DDE01)
Condition: Relapsing-remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: fingolimod
Intervention MeSH terms: Fingolimod Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 133.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: fingolimod; Biomarker; Multiple sclerosis; Relapsing-remitting multiple sclerosis

Summary:

      The purpose of this single visit extension study is to explore immune status in RRMS patients
      treated for at least 48 months with fingolimod. Long-term changes in T cell counts will be
      compared to short-term changes in immune status (baseline to month 6) after treatment start
      with fingolimod as assessed in the original Biobank study (CFTY720DDE01).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written informed consent before any assessment was performed.

          2. Randomized in study CFTY720DDE01 and received at least one dose of study drug
             (fingolimod) and completed the study.

          3. Continuous intake of fingolimod after end of study CFTY720DDE01 with a maximum
             treatment interruption of 3 months in total before entering this study.

          4. Parallel participation at study CFTY720DDE02 (Pangaea NIS) was allowed.

        Exclusion criteriat:

          1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
             female after conception and until the termination of gestation, confirmed by a
             positive human Chorionic Gonadotropin (hCG) laboratory test.

          2. Patients with onset of an acute relapse had to postpone their evaluation until deemed
             stable from relapse by treating physician, but at least for 1 month since end of
             relapse.

          3. Patients that received immunomodulating or immunosuppressive MS treatments other than
             fingolimod since completion of study CFTY720DDE01 as for example:
             Natalizumab,Alemtuzumab, Dimethyl fumarate, Teriflunomide, intravenous
             Immunoglobulins,Mitoxantrone, Methotrexate, Azathioprine or experimental
             immunomodulating-immunosuppressive therapies.
A Pilot Study Of Smoking Cessation Treatment Including Varenicline In Patients Scheduled For Planned Surgery
Condition: Smoking Cessation
Intervention: Varenicline
Intervention description: Varenicline film coated tablets - escalating dose with maximum dose of 1mg bd
Intervention MeSH terms: Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: smoking cessation; varenicline; elective surgery; wound infections; post-operative complications

Summary:

      It is possible to offer smoking cessation treatment including varenicline to patients
      scheduled for elective surgery. This study will evaluate whether or not this will enable some
      patients to quit smoking for up to 4 weeks prior to surgery and in turn, whether this may
      lead to reductions in post-operative complication such as wound infections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Smokers motivated to stop smoking scheduled for elective surgery

        Exclusion Criteria:

          -  Current or recent depression

          -  Current or recent suicidal ideation

          -  Uncontrolled or unstable clinically significant medical condition
Study of Sirolimus Versus Mycophenolate Liver Transplant Recipients With Recurrent Hepatitis C Virus (HCV)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Mycophenolate to sirolimus switch
Intervention description: Sirolimus given for 3 months instead of mycophenolate at a starting dose equivalent of 1 mg sirolimus equal to 1000 mg of mycophenolate.
Intervention MeSH terms: Mycophenolic Acid; Sirolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: sirolimus; everolimus; mycophenolic acid; hepatitis C virus; tacrolimus; viral load

Summary:

      Different immunosuppressive drugs used in transplantation may reduce the body's defences
      against infection differently. It is known that patients with Hepatitis C virus, known as
      HCV, who switched from azathioprine to mycophenolate mofetil experienced an increase in viral
      load. Despite this, mycophenolate mofetil is used because it prevents rejection more reliably
      than azathioprine. Sirolimus is an another immunosuppressive agent that reliably prevents
      rejection and may have antiviral activity. This study is designed to see if the viral load of
      HCV and other viruses is reduced by switching from mycophenolate to sirolimus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recurrent HCV after liver transplantation

          -  Taking mycophenolate mofetil

          -  Stable liver function

        Exclusion Criteria:

          -  Pregnant females or couples unwilling to use contraception

          -  Intolerance or allergy to sirolimus

          -  Patients taking anti-HCV therapy

          -  Patients taking medications known to alter the levels of sirolimus

          -  History of thromboembolic disease
Human Microbiome and Healthcare Associated Infections - Nursing Home Dwelling Older Veterans
Condition: Human Microbiome
MeSH terms: Cross Infection
Intervention: Intranasal Mupirocin and Topical Chlorhexidine
Intervention description: Antimicrobial antiseptic skin cleanser (4% chlorhexidine) for daily use on Day 1, 3 and 5 of Week 8 of the study. BACTROBAN NASAL ointment (mupirocin calcium ointment, 2%) for use intranasally twice-daily on Day 1, 2, 3, 4 and 5 of Week 8 of the study.
Intervention MeSH terms: Chlorhexidine; Mupirocin
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: intranasal mupirocin; topical chlorhexidine

Summary:

      The purpose of the research is to find out the effect of commonly used topical antibiotics on
      the bacteria that live in the nose, throat and on the skin of older adults. In addition, the
      investigators want to determine if these topical antibiotics affect how bacteria are spread
      in Community Living Centers of the VA Maryland Health Care System.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 50 years or older.

          -  Living in a participating nursing home for at least 80% of the past 3 months-

          -  Willing to provide anterior nares, posterior pharynx, skin and throat specimens over
             the study period.

          -  Willing to use intranasal mupirocin and topical chlorhexidine over a five day period.

          -  Provide signed and dated informed consent from subject or LAR.

        Exclusion Criteria:

          -  Recent history of MRSA colonization

          -  Use of mupirocin nasal ointment in past 3 months

          -  Use of topical chlorhexidine in past 3 months

          -  History of an allergic reaction to chlorhexidine or mupirocin
Attention & Memory Impairments in Menopausal Women
Condition: Symptomatic Menopause; Cognitive Impairments
Intervention: Lisdexamfetamine; Placebo
Intervention description: In a counterbalanced fashion, participants would receive titrated doses of LDX 20 to 60 mg/d for 4 weeks followed by a 2-week washout and then crossed over to the placebo tablets for another 4 weeks. All women will start with LDX 20 mg/d and then be titrated to 40 mg/d after 1 week and 60 mg/d after 2 weeks (as tolerated).; In a counterbalanced fashion, participants would receive placebo tablets for 4 weeks followed by a 2 week washout, then will receive titrated doses of LDX 20 to 60 mg/d for 4 weeks.
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 35.0
Sex: Female
Minimum age: 45 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Menopause; Aging; Memory; Women

Summary:

      The purpose of this study is to determine whether a medication called Vyvanse®
      (lisdexamfetamine; LDX) has an impact on cognitive functioning, specifically measures of
      sustained attention, verbal encoding and recall and working memory, in menopausal aged women.
      LDX is a medication used to treat attention deficit hyperactivity disorder (ADHD). The
      cognitive difficulties that menopausal women report experiencing are typical of adults who
      are diagnosed with ADHD. The investigators will assess whether or not LDX is effective in
      alleviating those cognitive disruptions when compared to a placebo.
    

Eligibility criteria:

        Inclusion Criteria:

        Women ages 45 to 60 will be eligible for this study if they:

          -  Are within 5 years of their last menstrual period;

          -  Are able to give written informed consent;

          -  Must have clear urine toxicology screen upon recruitment;

          -  Are fluent in written and spoken English;

          -  Must have negative urine pregnancy test if still menstruating.

        Exclusion Criteria:

          -  History of seizures;

          -  History of cardiac disease including known cardiac defect or conduction abnormality;

          -  Abnormal electrocardiogram during screening;

          -  Use of estrogen therapy within previous 6 months;

          -  Current pregnancy or planning to become pregnant.

          -  Presence of a contraindication to treatment with stimulant medication; this would
             include the presence of hypertension, coronary disease, atrial fibrillation, and
             arrhythmia.
Antiarrhythmic Effects of Spironolactone in Patients With ICDs
Condition: Ventricular Arrhythmias
MeSH terms: Arrhythmias, Cardiac
Intervention: spironolactone; placebo
Intervention description: aldosterone blocker; identical in appearance to spironolactone study drug
Intervention MeSH terms: Spironolactone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This was a prospective, double-blind, randomized trial that assigned patients to receive either spironolactone 25 mg/day or a placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: All participants, providers, investigators, and outcome assessors were blinded to treatment assignment. The pharmacy maintained a key to randomization that was not broken until the study was completed and all outcomes had been assessed.
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Anti-Arrhythmia Agents; Ventricular Fibrillation; Ventricular Tachycardia; Defibrillators, Implantable

Summary:

      This study will test whether spironolactone, an approved drug for among other things
      hypertension, will reduce the risk of severe arrhythmias in patients with implanted
      defibrillators. Half the patients in the study will get spironolactone and half will get a
      placebo. Neither the patients or their providers will know if they are getting spironolactone
      or placebo.
    

Eligibility criteria:

        Inclusion Criteria:

        -Patients were considered eligible for enrollment only if they had received

          -  an ICD therapy, either a shock or antitachycardia pacing (ATP),

          -  VT/VF in the previous 2 years or

          -  received an ICD for secondary prevention of sustained VT/VF in the previous 6 months.

        Exclusion Criteria:

        -Important exclusion criteria were

          -  an indication for spironolactone based on the RALES trial (EF of <35% and -New York
             Heart Association (NYHA) class III or IV),

          -  unstable angina,

          -  primary hepatic failure,

          -  known intolerance to spironolactone,

          -  a serum creatinine concentration of >2.5 mg/dL,

          -  a serum potassium concentration of >5.0 mmol/L, and

          -  a life expectancy of <2 years.
Evaluation of Efficacy and Hypothalamus-pituitary-adrenal Axis Suppression Due to Corticosteroids Intrabursal Injection
Condition: Tendinopathy; Adrenal Insufficiency
MeSH terms: Tendinopathy; Pituitary Diseases; Adrenal Insufficiency
Intervention: methylprednisolone acetate; Triamcinolone Acetonide
Intervention description: Single intrabursal ultrasound guided injection of 40 mg (1 ml) of methylprednisolone acetate; Single intrabursal ultrasound guided injection of 40 mg (1 ml) of triamcinolone acetonide
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Prednisolone hemisuccinate; Prednisolone phosphate; Triamcinolone diacetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: rotatory cuff calcific tendonitis; corticosteroids; US guided percutaneous treatment; methylprednisolone; triamcinolone; hypothalamus pituitary adrenal axis

Summary:

      The purpose of this study is to compare the efficacy and effects on the
      hypothalamus-pituitary-adrenal axis of a single intrabursal injection of two different types
      of corticosteroids (methylprednisolone and triamcinolone) in patients with calcific shoulder
      tendinopathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  painful rotator cuff calcific tendonitis demonstrated by ultrasounds

        Exclusion Criteria:

          -  pregnancy

          -  use of corticosteroids in the previous 2 months

          -  systemic chronic inflammatory or allergic diseases

          -  allergy to methylprednisolone or triamcinolone

          -  diabetes

          -  glaucoma

          -  coagulopathies or current treatment with antiaggregants or anticoagulants

          -  septic arthritis or infections

          -  calcific enthesopathy
Study of Oral Treatments for Hepatitis C
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: SOF/LDV (sofosbuvir/ledipasvir); PrOD (ombitasvir/paritaprevir/ritonavir with dasabuvir) (Phase 1 only); EBR/GZR (elbasvir/grazoprevir); Ribavirin
Intervention description: Sofosbuvir/Ledipasvir (400/90 mg) for approximately 12 to 24 weeks (treatment duration and use of ribavirin is per discretion of HCV provider); Ombitasvir/paritaprevir/ritonavir (12.5/75/50mg) (2 tablets taken orally) and Dasabuvir (250 mg tablet) (1 tablet twice daily) with food for 12 to 24 weeks (treatment duration as per HCV provider); Elbasvir/grazoprevir (50/100mg) tablet once daily with or without food with or without RBV for 12 to 16 weeks; 200 mg pills (1-3 pills, 1-2 times per day)
Intervention MeSH terms: Ritonavir; Ribavirin; Sofosbuvir; Grazoprevir; Ledipasvir; Elbasvir-grazoprevir drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1275.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis C

Summary:

      Phase 1 of this study compared the effectiveness of 3 approved DAA (direct-acting antiviral)
      HCV treatment regimens to learn whether they worked equally well under real-world conditions.
      Phase 2 of this study began early 2017 with removal of 1 DAA regimen, limiting randomization
      to just 2 FDA approved DAA regimens. Patients receiving HCV therapy in community and academic
      clinics were offered the opportunity to consent to be randomly assigned to one of three
      (phase 1) or one of two (phase 2) regimens and observed for outcomes. Once randomized, all
      medical care, laboratory testing, and any disease or side effect management were assumed by
      usual care conditions, and patient-reported outcomes were collected outside clinic in keeping
      with pragmatic design principles.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HCV Genotype 1a or 1b

          -  Adult patients (age 18 years or older)

          -  Patients being prescribed HCV treatment who can begin treatment with any of the three
             HCV treatments being studied (Harvoni (SOF/LDV), Viekira Pak (PrOD) (Phase 1 only), or
             Zepatier (EBR/GZR))

        Exclusion Criteria:

          -  Inability to provide written informed consent

          -  HARVONI® is not a covered drug on benefits formulary

          -  Current or historical evidence of hepatic decompensation (variceal bleeding, hepatic
             encephalopathy, or ascites)

          -  Child Pugh (CTP) B or C Cirrhosis (documented CTP calculation is required)

          -  Pregnant or breastfeeding women
Efficacy and Safety of Diclofenac 1.16% Gel in Subjects With Acute Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Intervention: Diclofenac diethylamine 1.16% gel; Placebo gel
Intervention description: Diclofenac diethylamine 1.16% gel; Placebo gel
Intervention MeSH terms: Diclofenac
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of diclofenac 1.16% gel
      compared with placebo applied four times a day in subjects with acute neck pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects, age range 18 and over.

          -  Patient with acute neck pain meeting baseline pain intensity level and duration

        Exclusion Criteria:

          -  Pain medication was taken within the 6 hours that precede randomization.

          -  Patient with chronic neck pain as defined as pain for 3 months or longer

          -  Any neck pain that is attributable to any organic disease, such as prolapsed disc,
             spondylolisthesis, osteomalacia, inflammatory arthritis, metabolic, neurological
             diseases or tumors.

          -  Any recent strains of the neck muscles documented by the clinical evaluation and
             anamnesis