bioihbjkbjnl/mcl2 huggingface dataset:
Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Abatacept; placebo
Intervention description: solution, intravenous injection, monthly, 169 days
weight based:
<60 kg = 500 mg
60 to 100 kg = 750 mg
>100 kg = 1 g; solution, intravenous injection, 0 mg, monthly, 169 days
Intervention MeSH terms: Abatacept
Phase: Phase 2
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess if Abatacept given for six months will prevent
      rheumatoid arthritis (RA) in patients who are at risk for the development of RA in comparison
      to placebo. High risk patients are defined as those having a positive laboratory test for
      anti-cyclic citrullinated peptide (anti-CCP2).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of undifferentiated arthritis

          -  Clinical synovitis of two or more joints

          -  At least one but not more than three of the criteria for diagnosis of RA (1987).

          -  No prior disease modifying anti-rheumatic drugs (DMARDs)/biologics.

          -  Duration of disease must be 18 months or less.

          -  Positive for antibodies against cyclic citrullinated peptides.

        Exclusion Criteria:

          -  Women of child bearing potential who are unwilling or unable to use an acceptable
             method to avoid pregnancy.

          -  Active vasculitis of a major organ system.

          -  Severe or recurrent bacterial infection.

          -  History of cancer in the last five years except certain skin cancers.

          -  Herpes zoster that resolved less than 2 months prior to enrollment
The Alberta Diet: Effectiveness Study
Condition: Type 2 Diabetes
Intervention: PANDA intervention
Intervention description: Participants will follow a menu plan and receive training in how to manage their diet in type 2 diabetes, following the recommendations of the Canadian Diabetes Association, 2008
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 73.0
Sex: All
Minimum age: 35 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The study hypothesis is that individuals with type 2 diabetes (T2D), who adhere to the PANDA
      intervention, will have improved compliance with the nutritional therapy recommendations of
      the Canadian Diabetes Association. Specific objectives of this proposal: The objectives of
      the investigators PANDA (Physical Activity and Nutrition for Diabetes in Alberta) are to (a)
      to devise and evaluate the efficacy of a multi-level, practical, nutrition intervention
      program that promotes the individual factors required for effective self-management practices
      AND that explicitly incorporate strategies to improve food availability, accessibility and
      acceptability and (b) to use these interventions as a means to examine the relationships
      between food availability, accessibility, acceptability, adherence to Nutrition Therapy
      Guidelines, and metabolic indicators of diabetes control in people with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes, and speak/write English.

          -  Have attended a diabetes education session delivered by their healthcare provider.

        Exclusion Criteria:

          -  Participants with type 1 diabetes, and those who are unable to speak English.

          -  People with end-stage renal disease or gastrointestinal diseases that require
             specialized diets will also be excluded.
Study Evaluating Inotuzumab Ozogamicin (CMC-544) Plus Rituximab In Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Condition: Lymphoma, B-Cell
MeSH terms: Lymphoma; Lymphoma, B-Cell
Intervention: inotuzumab ozogamicin (CMC-544); rituximab
Intervention description: 1.8 mg/m^2 every 21 days by intravenous infusion, 3 to 6 doses; 375 mg/m^2 two days before cycle 1 by intravenous infusion; 375 mg/m^2 every 21 days by intravenous infusion, 3 to 6 doses
Intervention MeSH terms: Rituximab; Inotuzumab Ozogamicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diffuse large b-cell lymphoma; inotuzumab ozogamicin; autologous stem cell transplant

Summary:

      The purpose of this study is to evaluate inotuzumab ozogamicin in combination with rituximab
      prior to an autologous stem cell transplant (aSCT) in patients with relapsed/refractory
      diffuse large B-cell Non-Hodgkin's lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  CD20/CD22-positive diffuse large B-cell NHL that has relapsed after 1 or 2 prior
             therapies; one prior therapy must include anthracyclines and one must include
             rituximab in combination with chemotherapy

          -  Relapsed/disease progression within 12 months after start of prior therapy and/or
             secondary International Prognostic Index (sIPI) score greater than 1

          -  Eligible for autologous stem cell transplant (aSCT)

        Exclusion Criteria:

          -  Prior allogeneic hematopoietic stem cell transplant

          -  Within 6 months prior to test article: autologous transplant, treatment with anti-CD22
             antibodies, radio-immunotherapy

          -  Veno-occlusive disease or sinusoidal obstruction syndrome, chronic liver disease,
             systemic vasculitides, current or chronic hepatitis B or C infection
A Study of Tarceva (Erlotinib) and Avastin (Bevacizumab) in Patients With Advanced or Metastatic Liver Cancer.
Condition: Liver Cancer
MeSH terms: Liver Neoplasms
Intervention: bevacizumab (Avastin); erlotinib (Tarceva)
Intervention description: 5 mg/kg iv on day 1 of each 2 week cycle.; 150 mg orally (po) daily.
Intervention MeSH terms: Bevacizumab; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study evaluated the efficacy and safety of a combination of Tarceva and
      Avastin in patients with advanced or metastatic liver cancer. Patients were treated with
      Tarceva 150 mg po daily plus Avastin 5 mg/kg intravenous (iv) every 2 weeks. The anticipated
      time on study treatment was until disease progression, and the target sample size was <100
      individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, ≥ 18 years of age;

          -  advanced or metastatic liver cancer;

          -  ≥ 1 measurable lesion, not previously treated with local therapy within 4 weeks of
             enrollment.

        Exclusion Criteria:

          -  prior or concomitant systemic anti-cancer treatment for advanced disease;

          -  patients at high risk of variceal bleeding;

          -  clinically significant cardiovascular disease;

          -  major surgery, open biopsy, or significant traumatic injury within 4 weeks of study
             start.
Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Adults With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3
Condition: Non-Alcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease; Fibrosis
Intervention: SEL; SIM
Intervention description: SEL tablet administered orally once daily; Simtuzumab (SIM) 125 mg/mL single-dose vials administered subcutaneously once weekly
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: GS-4997; Non-alcoholic fatty liver disease (NAFLD); Fibrosis; Simtuzumab (SIM); Apoptosis signal-regulating kinase 1; ASK1 inhibitor

Summary:

      The primary objective of this study is to evaluate the safety and tolerability of GS-4997
      (selonsertib [SEL]) alone or in combination with simtuzumab (SIM) in adults with nonalcoholic
      steatohepatitis (NASH) and fibrosis stages F2-F3. Participants will be randomized in a
      2:2:1:1:1 ratio to 1 of 5 study treatment arms.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Males and non-pregnant, non-lactating females

          -  Evidence of NASH with fibrosis on biopsy

        Key Exclusion Criteria:

          -  Cirrhosis of the liver (e.g. Brunt/Kleiner score of F4)

          -  Other causes of liver disease including viral hepatitis and alcoholic liver disease

          -  Any history of decompensated liver disease, including ascites, hepatic encephalopathy
             or variceal bleeding

          -  History of liver transplantation

          -  Alcohol consumption greater than 21 oz/week for males or 14 oz/week for females (1
             oz/30 mL of alcohol is present in 1 12 oz/360 mL beer, 1 4 oz/120 mL glass of wine,
             and a 1 oz/30 mL measure of 40% proof alcohol)

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Recovery After Total Intravenous Anesthesia With Ketofol Versus Mixture of Ketofol and Lidocaine for Short Pediatric Surgery
Condition: Surgical Procedure, Unspecified
Intervention: ketamine, propofol; ketamine, propofol, lidocaine
Intervention description: anesthesia with ketofol in pediatric surgery; anesthesia with ketofol plus lidocaine in pediatric surgery
Intervention MeSH terms: Lidocaine; Ketamine; Propofol
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 200.0
Sex: All
Minimum age: 1 Year
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      Two hundred children aged 1-12 years undergoing short surgery will be randomized into two
      groups. Ketofol will be used for induction and maintenance of anesthesia in group l. .Ketofol
      with lidocaine will be prepared for group ll. A reducted McFarlan infusion dose will be used.
      Extubating time, duration of anesthesia, length of stay in post-anesthesia care unit (PACU)
      will be recorded.
    

Eligibility criteria:

        Inclusion Criteria:

          -  surgical procedures max 60 min ASA I and II

        Exclusion Criteria:

          -  ASA > II surgical procedures longer than 60 min
A Study to Assess the Safety of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive Impairment
Condition: Parkinson Disease
MeSH terms: Parkinson Disease; Cognitive Dysfunction
Intervention: GRF6021; Placebo
Intervention description: GRF6021 for IV infusion; Placebo for IV infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 79.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Parkinson's Disease; Dementia

Summary:

      This study will evaluate the safety, tolerability, and potential effects on cognition of
      GRF6021, a plasma-derived product, administered as an intravenous (IV) infusion, to subjects
      with Parkinson's disease and cognitive impairment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Parkinson's Disease (PD), with at least 1 year of PD symptoms.

          -  Diagnosis of PD with mild cognitive impairment (PD-MCI) or probable or possible
             Parkinson's disease dementia according to Movement Disorder Society's Clinical
             Diagnostic criteria.

          -  Score on the Montreal Cognitive Assessment (MoCA) of 13-25.

          -  Modified Hoehn and Yahr Stages 1-4.

          -  Modified Hachinski Ischemic Scale (MHIS) score of 4 or less.

        Exclusion Criteria:

          -  History of blood coagulation disorders or hypercoagulability.

          -  Current use of anticoagulant therapy. Use of antiplatelet drugs (e.g., aspirin or
             clopidogrel) is acceptable.

          -  Prior hypersensitivity reaction to any human blood product or any IV infusion.

          -  Treatment with any human blood product, including transfusions and IV immunoglobulin,
             during the 6 months prior to screening.

          -  History of immunoglobulin A or haptoglobin deficiency; stroke, anaphylaxis, or
             thromboembolic complications of IV immunoglobulins.

          -  Heart disease, as evidenced by myocardial infarction, unstable, new onset or severe
             angina, or congestive heart failure in the 6 months prior to dosing

          -  Hemoglobin < 10 g/dL in women and < 11 g/dL in men.
Post-Myocardial Infarction Remodeling Prevention Therapy
Condition: Acute Myocardial Infarction; Pacing Therapy; Cardiac Remodeling; Heart Failure
MeSH terms: Myocardial Infarction; Infarction
Intervention: Single Site Pacing; Dual Site Pacing
Intervention description: Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.; Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 129.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to demonstrate the feasibility of pacing as a therapy to prevent
      adverse remodeling of the myocardium following an acute myocardial infarction (MI) in
      patients at highest risk for adverse myocardial remodeling.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Myocardial Infarction (MI) within the past 10 days

          -  Peak Creatine Phosphokinase (CPK) greater than 3000 Units/Litre (U/L) at time of MI,
             or a troponin T (TnT) greater than 10 micrograms/Litre (mcg/L)

          -  At least 18 years old

          -  Willing to comply with the protocol

        Exclusion Criteria:

          -  Documented MI greater than 10 days

          -  Chronic renal disease, as defined by estimated glomerular filtration rate (eGFR) less
             than 30 milliliters/minute/1.73 square meter

          -  Life expectancy less than 18 months, as determined by a physician

          -  Existing pacemaker, Implantable Cardioverter Defibrillator (ICD), or Cardiac
             Resynchronization Therapy (CRT) device

          -  QRS duration greater than 120 milliseconds (ms)

          -  Coronary Artery Bypass Graft (CABG) within 30 days prior to MI, or CABG procedure
             planned

          -  Third degree atrioventricular (AV) block or symptomatic bradyarrhythmia

          -  Persistent atrial fibrillation (AF) that is not self terminating within 7 days or is
             terminated electrically or pharmacologically

          -  Permanent AF that is non self terminating, with cardioversion failed or not attempted
             within the past year

          -  New York Heart Association (NYHA) Class IV

          -  Non-ischemic cardiomyopathy

          -  Pregnant or planning to become pregnant during the study

          -  Enrolled or planning to participate in a concurrent drug and/or device study during
             the course of this clinical trial. Co-enrollment in concurrent trials is only allowed
             with documented pre-approval from Medtronic, documenting that there is not a concern
             that co-enrollment could confound the results of this trial.

          -  Breast feeding

          -  Of a vulnerable population as determined by local law or requirement, or a physician
Glycopyrrolate/Formoterol Fumarate MDI Compared With Spiriva® as An Active Control in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: PT003; PT001; PT005; Tiotropium inhalation powder
Intervention description: PT003 MDI administered as two puffs BID for 7 days; PT001 MDI administered as two puffs BID for 7 days; PT005 MDI administered as two puffs BID for 7 days; Taken as 1 capsule containing 18 µg of Tiotropium via the Handihaler DPI for 7 days
Intervention MeSH terms: Tiotropium Bromide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 159.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      The primary objective of this study is to assess the efficacy of Glycopyrrolate/Formoterol
      Fumarate MDI relative to individual components (GP MDI and FF MDI) in subjects with moderate
      to severe COPD
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Signed written informed consent

          -  40 - 80 years of age

          -  Clinical history of COPD with airflow limitation that is not fully reversible

          -  Females of non-child bearing potential or females of child bearing potential with
             negative pregnancy test and acceptable contraceptive methods

          -  Current/former smokers with at least a 10 pack-year history of cigarette smoking

          -  A measured post-bronchodilator FEV1/FVC ratio of < or = 0.70

          -  A measured post-bronchodilator FEV1 > or = 750ml or 30% predicted and < or = 80% of
             predicted normal values

          -  Able to change COPD treatment as required by protocol

        Key Exclusion Criteria:

          -  Women who are pregnant or lactating

          -  Primary diagnosis of asthma

          -  Alpha-1 antitrypsin deficiency as the cause of COPD

          -  Active pulmonary diseases

          -  Prior lung volume reduction surgery

          -  Abnormal chest X-ray not due to the presence of COPD

          -  Hospitalized due to poorly controlled COPD within 3 months of Screening

          -  Clinically significant medical conditions that preclude participation in the study
             (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma,
             symptomatic prostatic hypertrophy)

          -  Cancer that has not been in complete remission for at least 5 years

          -  Treatment with investigational study drug or participation in another clinical trial
             or study within the last 30 days or 5 half lives

        Other inclusion/exclusion criteria as defined in the protocol
A Trial for Patients With Advanced/Recurrent Cervical Cancer
Condition: Cervical Intraepithelial Neoplasia; Uterine Neoplasms; Genital Neoplasms, Female
MeSH terms: Neoplasms; Uterine Cervical Dysplasia; Uterine Neoplasms; Genital Neoplasms, Female
Intervention: Pemetrexed
Intervention description: Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression.
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: Female
Healthy volunteers: No

Summary:

      This phase II trial is studying the antitumor activity of single agent pemetrexed 900mg/m2 IV
      over 10 minutes in patients with recurrent cervical cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recurrent squamous or non-squamous cell carcinoma of the cervix with documented
             disease progression

          -  Measurable disease

          -  Gynecologic Oncology Group (GOG) performance status 0-2

          -  Patients must have received one prior systemic chemotherapy for persistent or
             recurrent disease

          -  Patients with mild to moderate renal insufficiency should avoid taking non-steroidal
             anti-inflammatory drugs (NSAIDs_ with short elimination half-lives for a period of 2
             days before, the day of, and 2 days following administration of pemetrexed.

          -  All patients taking NSAIDs with longer half-lives, should interrupt dosing for at
             least 5 days before, the day of, and 2 days following pemetrexed administration.

          -  Folic Acid (350-1000 ug) must be given daily beginning approximately 5-7 days prior to
             first does of pemetrexed and continuing daily until 3 weeks after the last dose of
             study therapy.

          -  Vitamin B12 (1000 ug) will be administered as an intramuscular injection approximately
             1 to 2 weeks prior to first dose of pemetrexed and repeated approximately every 9
             weeks until 3 weeks after the last dose of study therapy

        Exclusion Criteria:

          -  Prior Pemetrexed

          -  Patients who have received radiation to more than 25% of marrow bearing areas

          -  Any evidence of other malignancy within last 5 years, with exception of non-melanoma
             skin cancer
Nevanimibe HCl for the Treatment of Classic CAH
Condition: Congenital Adrenal Hyperplasia
MeSH terms: Adrenal Hyperplasia, Congenital; Adrenogenital Syndrome; Hyperplasia
Intervention: Nevanimibe hydrochloride
Intervention description: During the 16-week treatment period, all subjects will begin dosing with nevanimibe HCl 500 mg BID and be dose titrated to 1000 mg BID, 1500 mg BID, and 2000 mg BID as needed based on serum 17-OHP assessments every 4 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: CAH; nevanimibe

Summary:

      This is a multicenter, intra-subject dose-titration open-label study of nevanimibe
      hydrochloride (HCl) for the treatment of classic congenital adrenal hyperplasia (CAH).
      Following a Screening Period of approximately 2-14 weeks, eligible subjects will enter a
      Baseline Period of approximately 2-8 weeks and then a 16-week Treatment Period. It is
      anticipated that the overall duration of the study per subject will range from 24-42 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented historical diagnosis of classic CAH due to 21-hydroxylase deficiency and/or
             historical documentation of elevated 17-OHP

          -  Chronic glucocorticoid replacement therapy for at least 6 consecutive months prior to
             screening

          -  Stable glucocorticoid and mineralocorticoid regimen for at least 4 weeks prior to
             screening and throughout the treatment period of the study

        Exclusion Criteria:

          -  Nonclassic CAH

          -  Other causes of adrenal insufficiency

          -  HIV, hepatitis B, or hepatitis C

          -  AST or ALT >2x ULN, bilirubin or serum creatinine >1.5x ULN