bioihbjkbjnl/mcl2 huggingface dataset:
A Continuation Trial for Subjects With Rheumatoid Arthritis That Have Completed Protocol LBRA01
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: belimumab
Intervention description: IV 10mg/kg Q28 days
Intervention MeSH terms: Belimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 155.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; RA

Summary:

      This is a continuation trial of LymphoStat-B™ to evaluate the long-term safety in subjects
      with Rheumatoid Arthritis that completed study LBRA01 and benefitted from treatment.
    

Eligibility criteria:

        Primary Inclusion Criteria:

          1. Have completed the LBRA01 trial.

          2. Have achieved at least an ACR20 response at the end of LBRA01.

        Primary Exclusion Criteria:

          1. Have switched NSAIDs due to worsening RA disease activity, used more than 10 mg/day of
             oral prednisone, or were given a corticosteroid injection during the last 30 days of
             LBRA01.

          2. Required a new DMARD (not otherwise excluded in protocol LBRA01) to replace an
             ineffective one, or an additional DMARD (not to exceed 2 DMARDs in total) within the
             last 60 days of LBRA01.

          3. Used prohibited medications during their participation in LBRA01. These medications
             include the following:

               -  Other investigational agents.

               -  Biologic response modifiers

               -  Cyclophosphamide.

               -  Corticosteroid injections (except 1 injection of up to 40 mg of prednisone into
                  an inflamed joint or intramuscularly every 6 months).

               -  2 new DMARDs.

               -  1 new DMARD plus high dose prednisone >10 mg/day.
Spironolactone in Adult Congenital Heart Disease
Condition: Congenital Heart Disease; Heart Failure; Endomyocardial Fibrosis
MeSH terms: Heart Failure; Heart Diseases; Heart Defects, Congenital; Endomyocardial Fibrosis; Fibrosis
Intervention: Spironolactone 25mg; Placebo
Intervention description: Spironolactone 25 mg daily for 12 months; Placebo daily for 12 months
Intervention MeSH terms: Spironolactone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to see if the study drug called spironolactone reduces fibrous
      (stiffening) in heart muscle tissue and improves heart function. Subjects from the study
      titled "Heart Failure in Congenital Heart Disease: the role of myocardial fibrosis" who have
      evidence of heart dysfunction and/or evidence of fibrosis (stiffening) in the heart muscle
      will be asked to take part in this study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Fibrosis index ≥29%, or

          2. Evidence of cardiovascular dysfunction including any of the following:

               -  Systemic ejection fraction <55%,

               -  NYHA 2-3

               -  6-minute walk distance <500 m.

          3. Completion of Visit 1 of the study Heart Failure in Congenital Heart Disease: the role
             of myocardial fibrosis" (eIRB # 3665) including meeting all inclusion for that study
             (Aged 18-80, Known congenital heart disease).

          4. Tetralogy of Fallot, cyanotic congenital heart disease, or a systemic right ventricle.

        Exclusion Criteria:

          1. Patient currently taking spironolactone or previously taking spironolactone within the
             last 6 months.

          2. Serum potassium ≥5.0 mmol/L at the initial visit, if not taking potassium supplements.
             Patients will be eligible if a repeat potassium is <5.0 mmol/L after potassium
             supplements have been discontinued.

          3. Moderate/severe systemic atrioventricular valve regurgitation,

          4. Likely to undergo cardiac surgery, pacemaker implantation, or possible transplantation
             within one year (all self-reported),

          5. Unwilling to commit to return visits including mandatory blood draws for potassium,

          6. Renal insufficiency (estimated creatinine clearance < 30 ml/min/1.73m2),

          7. Positive urine pregnancy test.

          8. Any contraindication to MRI.
Phase 2 Evaluation of Multi-modality Algorithm for Non-metastatic Adenocarcinoma of Pancreas or Ampulla
Condition: Ductal Adenocarcinoma of Pancreas; Adenocarcinoma of Ampulla
MeSH terms: Adenocarcinoma
Intervention: Gemcitabine and nanoparticle albumin bound paclitaxel; 5-fluorouracil and irinotecan; Preoperative chemoradiation; Definitive resection
Intervention description: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles; FOLFIRI.3 given every 14 days x 4 cycles; Pre-operative chemoradiation to 40 Gy in 20 fractions; Definitive surgical resection of primary tumor
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Gemcitabine; Fluorouracil; Irinotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      Patients diagnosed with pancreatic cancer without clinically detectable metastatic disease
      will be treated with standardized systemic chemotherapy, followed by chemoradiation, and then
      surgical resection for those with resectable or borderline resectable disease. The primary
      endpoint is disease-free survival at 1 yr from initiation of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic proof of adenocarcinoma consistent with ductal carcinoma of pancreas or
             ampulla, with no evidence of metastatic disease by clinical exam or cross-sectional
             imaging.

          -  Fitness for chemotherapy in judgement of treating physician

          -  Bilirubin < 4 (any means of biliary drainage acceptable)

        Exclusion Criteria:

          -  Medical or mental illness precluding provision of informed consent

          -  Pregnancy

          -  Active infection for which neutropenia would pose high risk of mortality
Assessment of LCZ696 and Valsartan in Asian Patients With Salt-sensitive Hypertension
Condition: Salt-sensitive Hypertension
MeSH terms: Hypertension; Hypersensitivity
Intervention: Valsartan; LCZ696
Intervention description: Valsartan 320mg tablet once daily; LCZ696 400mg tablet once daily
Intervention MeSH terms: Valsartan; Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 2
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hypertension, salt sensitivity, valsartan, LCZ696

Summary:

      This study will evaluate the effect of LCZ696 and valsartan on natriuresis, diuresis, and
      blood pressure in salt-sensitive Asian hypertensive patients.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Written informed consent must be obtained before any study assessment is performed.

          -  Males and females of non-childbearing potential and of legal age (at least 18 years or
             older as defined by local law).

          -  Asian patients with mild to moderate essential hypertension, untreated or currently
             taking antihypertensive therapy with up to two drugs.

        Key Exclusion Criteria:

          -  Women of child-bearing potential.

          -  History of angioedema, drug-related or otherwise

          -  History of hypersensitivity to LCZ696, valsartan, or drugs of similar chemical
             classes.

          -  Severe hypertension (grade 3 of WHO classification; msDBP ≥100 mmHg and/or msSBP ≥ 180
             mmHg) at screening or at the end of the washout period.

          -  History or evidence of a secondary form of hypertension,

          -  Transient ischemic cerebral attack (TIA) during the 12 months prior to screening or
             any history of stroke.

          -  History of myocardial infarction, coronary bypass surgery or percutaneous coronary
             intervention (PCI) during 12 month prior to screening.

          -  Current or history of hypertensive retinopathy.

          -  Previous or current diagnosis of heart failure (NYHA Class II-IV).

          -  Clinically significant valvular heart disease at screening.

        Other protocol defined inclusion/exclusion criteria may apply
A Study of Safety and Efficacy of CNTO 148 in Patients With Severe Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: CNTO148; Placebo
Intervention description: Type=exact type, unit=mg, number=50, 75, 100, 150, 200 and 300, form=injection, route=subcutaneous. Every 4 weeks partciapnts will receive injections in 4 parallel treatment arms; Type=exact type, unit=mg, form=injection, route=subcutaneous. Placebo will be given from from Week 0 through Week 52.
Intervention MeSH terms: Golimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 309.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Asthma; Severe Persistent Asthma; Subcutaneous injections; Immunology disorder; Breathlesness

Summary:

      The purpose of this study is to evaluate the effectiveness and safety of CNTO 148 (golimumab)
      in patients with severe persistent asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Physician diagnosis of asthma for greater than or equal to 3 years and a diagnosis of
             severe persistent asthma forgreater than or equal to 1 year prior to screening

          -  Continuous treatment with high dose Inhaled corticosteroids (ICS) and long acting
             beta-agonist for at least 3 months prior to screening

          -  Have evidence of at least 1 of the following in the 5 years prior to screening or
             during screening, reversible airway obstruction greater than or equal to 12 percentage
             change in forced expiratory volume in 1 second (FEV1) postbronchodilator; Diurnal
             variation in peak expiratory flow rate (PEFR) greater than or equal to 30 percentage
             change) and airway hyperresponsiveness

          -  Estimated frequency of symptoms on more than one-third of days for at least 3 months
             prior to screening (eg, wheezing, breathlessness, chest tightness, cough, nocturnal
             awakening) despite treatment with high dose ICS and long-acting β2-agonist (LABA),
             with or without continuous oral corticosteroids

          -  Score of greater than or equal to 2 points on the asthma control questionnaire at
             screening.

        Exclusion Criteria:

          -  Diagnosis of chronic obstructive pulmoanry disease (COPD), cystic fibrosis, or other
             significant respiratory disorder

          -  Worsening of asthma symptoms that required treatment with an addition or increase in
             oral corticosteroids dose (steroid burst) in the 4-week period prior to the screening
             visit

          -  Life-threatening asthma attack requiring cardiopulmonary support (eg, intubation) in
             the 6-month period prior to screening

          -  Have ever used alkylating agents (eg, chlorambucil or cyclophosphamide)

          -  Concomitant diagnosis or any history of congestive heart failure (CHF), including
             medically controlled CHF.
Sofosbuvir/Velpatasvir Fixed Dose Combination in Participants With Chronic Hepatitis C Virus Infection Who Have Received a Liver Transplant
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Virus Diseases; Hepatitis
Intervention: SOF/VEL
Intervention description: 400/100 mg tablet administered orally once daily
Intervention MeSH terms: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to evaluate the efficacy, safety, and tolerability
      of sofosbuvir /velpatasvir (SOF/VEL) fixed-dose combination (FDC) in participants with
      chronic hepatitis C virus (HCV) who have received a liver transplant.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  History of chronic HCV infection (≥ 6 months)

          -  HCV genotype 1, 2, 3, 4, 5, 6, or indeterminate

          -  Liver transplant ≥ 3 months prior to screening

          -  Male and nonpregnant/ non-lactating female individuals without cirrhosis or with
             compensated cirrhosis

        Key Exclusion Criteria:

          -  History of clinically significant illness or any other medical disorder that may
             interfere with individual's treatment, assessment or compliance with the protocol,

          -  Co-infection with HIV or hepatitis B virus

          -  Known hypersensitivity to study medication,

          -  Use of any prohibited concomitant medications as within with window before the Day 1
             visit.

          -  De novo or recurrent hepatocellular carcinoma posttransplant

        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
GB001 in Adult Participants With Chronic Rhinosinusitis
Condition: Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP); Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
MeSH terms: Sinusitis; Nasal Polyps; Polyps
Intervention: GB001; Placebo
Intervention description: film-coated oral tablet; film-coated oral tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: GB001; Gossamer Bio; Gossamer; Nasal Polyposis; CRSwNP; CRSsNP

Summary:

      A Phase 2a, randomized, double-blind, placebo-controlled, multi-center study to evaluate the
      efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of GB001 compared with
      placebo over 16 weeks of treatment in patients with chronic rhinosinusitis with or without
      nasal polyposis (NP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  A diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP) or chronic
             rhinosinusitis without nasal polyps (CRSsNP) by a physician at least 12 weeks before
             Screening Visit

          -  Treated with stable intranasal corticosteroid (INCS) for at least 2 months prior to
             Screening Visit

          -  Presence of at least 2 nasal symptoms: nasal blockage/ obstruction/congestion or nasal
             discharge or facial pain/pressure or reduction/loss of smell

          -  Women of childbearing potential must use an acceptable method of contraception

        Exclusion Criteria:

          -  Sino-Nasal Outcome Test-22 (SNOT-22) score < 20 at screening

          -  Asthma or chronic obstructive pulmonary disease (COPD) patients that are current
             smokers

          -  Use of other investigational drugs within 30 days, or within 5 half-lives, whichever
             is longer, prior to Screening Visit

          -  Pregnant or breastfeeding

          -  Pre-existing clinically important co-morbidities

          -  Regular use of systemic corticosteroids or immunosuppressive treatments

        Other protocol-defined inclusion/exclusion criteria will apply.
Supporting the Health of Adults Undergoing Orthopedic Surgery During the Recovery Period
Condition: Delirium
MeSH terms: Delirium
Intervention: donepezil; Placebo
Intervention description: 5 mg each day for 30 days; Encapsulated cornstarch One capsule daily for 30 days
Intervention MeSH terms: Donepezil
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No
Keywords: Delirium; Postoperative confusion; Hip fracture; Long bone fracture

Summary:

      Delirium (acute confusion) is a highly prevalent condition among hospitalized elders with
      substantial morbidity within the hospital and beyond. Particular patient populations are at
      high risk for poor outcomes after an episode of delirium. Patients with hip and other long
      bone fractures are at increased risk of developing delirium (acute confusion) which impedes
      functional recovery. This is a pilot study to test the tolerability and efficacy of
      donepezil, a cholinesterase inhibitor medication used commonly in persons with dementia, for
      the prevention of new or worsening delirium in aged hip and other long-bone fracture
      patients. Additional purposes involve gathering a small amount of patients' serum to better
      understand the pathophysiology of delirium in this population.

      The purposes of this pilot study are to determine: 1) the safety and tolerability a
      cholinesterase inhibitor medication) in aged hip and long bone fracture patients, 2) To
      obtain estimates of subject accrual and preliminary estimates of effect size on the
      development of new delirium symptoms to allow for planning of a larger, definitive trial, 3)
      To better understand the underlying causes of delirium by examining whether a measure of
      blood anticholinergic activity relates to the incidence and persistence of delirium symptoms,
      and 4) To explore the interaction between anticholinergic activity, donepezil therapy, and
      delirium symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  hip or other long bone fracture undergoing operative repair

          -  age of 70 years or older

          -  the ability to communicate effectively in English (including adequate hearing)

          -  residence within a 50 mile radius of the BIDMC

          -  life expectancy 6 months or greater

          -  not currently on cholinesterase inhibitor therapy

          -  not with known hypersensitivity to cholinesterase inhibitors

          -  not a previous study participant or refusal

        Exclusion Criteria:

          -  patients with sick sinus syndrome or greater than 1st degree AV block without a
             pacemaker

          -  patients with a pathologic fracture due to metastatic cancer

          -  patients with advanced dementia or total functional dependence.
Ubiquinol in Parkinson's Disease: Safety, Tolerability, and Effects Upon Oxidative Damage and Mitochondrial Biomarkers
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: Ubiquinol; Placebo
Intervention description: Ubiquinol caplets 600mg/day; 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: 11.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Parkinson Disease; ubiquinol; CoQ10; magnetic resonance spectroscopy; lactate; glutathione

Summary:

      The purpose of this study is to find out whether ubiquinol is well tolerated, can affect the
      symptoms of Parkinson's Disease and change the energy levels in the brain. Subjects will be
      randomized to taking ubiquinol or placebo and will have a neurological evaluation, magnetic
      resonance spectroscopy (MRS) and blood test for biological markers taken during the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of PD according to the Untied Kingdom (UK) Brain Bank Criteria, and
             confirmed by a Movement Disorders neurologist;

          -  age 40-75 years; diagnosis within 5 years of study participation;

          -  PD medications able to remain at stable doses in the opinion of the enrolling
             investigator;

          -  able to undergo MRI;

          -  absence of significant medical, psychiatric, and other neurological disease;

          -  absence of dementia and Mini-Mental State Examination (MMSE) > 26.

        Exclusion Criteria:

          -  failure to meet diagnosis by above criteria;

          -  time since diagnosis > 5 years before study participation;

          -  PD medications not predicted to remain at stable doses in the opinion of the enrolling
             investigator;

          -  unable to undergo MRI;

          -  unable to comply with informed consent process;

          -  presence of significant medical, psychiatric (including major depressive disorder) or
             other neurological (including epilepsy, brain tumor, stroke) disease;

          -  diagnosis of dementia and/or MMSE 26 or lower;

          -  possibility of pregnancy (negative test required in women of childbearing age);

          -  taking medications including antipsychotic agents and dopamine- blocking anti-emetic
             agents;

          -  taking Coenzyme Q10;

          -  participation in another clinical trial within the last 3 months.
Pegylated Recombinant Mammalian Uricase (PEG-uricase) as Treatment for Refractory Gout
Condition: Gout
MeSH terms: Gout
Intervention: Pegloticase
Intervention description: 8 mg of Pegloticase administered IV every 3 weeks; total number of infusions is 5
Intervention MeSH terms: Rasburicase
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gout; Tophi; Tophaceous gout; Allergy to allopurinol; Post-transplant gout

Summary:

      The purpose of this study is to determine whether PEG-uricase (a chemically modified
      recombinant mammalian enzyme that degrades uric acid) is effective in controlling
      hyperuricemia in patients with chronic gout, who cannot tolerate, or have not responded
      adequately, to conventional therapy for gout.

      Funding Source - FDA OOPD
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >18 years

          -  Symptomatic gout

          -  Serum uric acid >7 mg/dL

          -  Intolerance of, or inadequate response to, conventional therapy for gout

          -  Women of childbearing potential must have a negative serum pregnancy test and must use
             an approved birth control method

        Exclusion Criteria:

          -  End stage renal failure that requires dialysis

          -  Concurrent use of uric-acid lowering agents

          -  Glucose-6-phosphate dehydrogenase (G6PD) deficiency

          -  A history of anaphylactic reaction to a recombinant protein

          -  Concurrent use of immunosuppressive therapy (except as needed for prevention of
             rejection of a transplanted organ, or prednisone at 10 mg a day or less for treatment
             of gout flares)

          -  A medical or psychological condition which, in the opinion of the investigator, might
             create undue risk to the subject