bioihbjkbjnl/mcl2 huggingface dataset:
A Single-dose Study to Investigate the Effects of 4 Different Doses of Inhaled AZD8683 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: Chronic Obstructive Pulmonary Disease; COPD
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: AZD8683; Placebo; Tiotropium
Intervention description: AZD8683 administered via inhalation; Placebo administered via inhalation; Tiotropium administered via inhalation
Intervention MeSH terms: Tiotropium Bromide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; Chronic obstructive pulmonary disease

Summary:

      This study in Chronic Obstructive Pulmonary Disease (COPD) patients will investigate the
      bronchodilatory effect of AZD8683. AZD8683 will be tested versus placebo and an active
      comparator.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of informed consent prior to any study specific procedures Male or female,
             age ≥ 40 years at Visit 1. Women must be of non-childbearing potential or must have
             been stable on a highly effective contraceptive method for at least 3 months prior to
             Visit 1 and be willing to continue until follow-up

          -  Clinical diagnosis of COPD for more than 1 year at Visit 1

          -  FEV1 ≥ 30 to < 80% of the predicted normal value (post-bronchodilator) at Visit 2 and
             post-bronchodilator FEV1/FVC < 70%

          -  Reversible airway obstruction

        Exclusion Criteria:

          -  Significant disease or disorder which, in the opinion of the Investigator, may either
             put the patient at risk because of participation in the study, or influence the result
             of the study, or the patient's ability to participate in the study.

          -  An exacerbation of COPD (defined as use of oral/parenteral glucocorticosteroids (GCS)
             and/or antibiotics and/or hospitalisation related to COPD) within 6 weeks of Visit 1or
             during the enrolment period

          -  Treatment with systemic GCS within 6 weeks of Visit 2 or during the enrolment period

          -  Respiratory tract infection of clinical relevance within 30 days of Visit 4, as judged
             by the Investigator

          -  Long-term oxygen therapy, as judged by the Investigator
EEG Studies of Sevoflurane-Induced General Anesthesia
Condition: Anesthesia
Intervention: Sevoflurane; Ketamine
Intervention description: Subjects will received sevoflurane for approximately 60 minutes.; Subjects will received sevoflurane and ketamine for approximately 60 minutes.
Intervention MeSH terms: Ketamine; Sevoflurane
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The investigators are performing this research study to find out how and where the anesthetic
      drugs sevoflurane and ketamine act in the brain. Sevoflurane and ketamine are anesthetics (a
      drug or agent used to decrease or eliminate the feeling of pain by causing unconsciousness).
      The investigators will study the brain using a machine that records the brain's electrical
      activity, called an electroencephalogram (EEG).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between the ages of 18 and 50

          -  Normal body weight and habitus, BMI ≤ 30

          -  Non-smoker

          -  American Society of Anesthesiologists (ASA) physical status classification P1

        Exclusion Criteria:

          -  Chronic health conditions
Open Label Extension of ISIS 301012 (Mipomersen) to Treat Familial Hypercholesterolemia
Condition: Lipid Metabolism, Inborn Errors; Hypercholesterolemia, Autosomal Dominant; Hyperlipidemias; Metabolic Diseases; Hyperlipoproteinemia Type II; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Infant, Newborn, Diseases; Metabolic Disorder; Congenital Abnormalities; Hypercholesterolemia; Hyperlipoproteinemias; Dyslipidemias; Lipid Metabolism Disorders
MeSH terms: Congenital Abnormalities; Hyperlipoproteinemia Type II; Genetic Diseases, Inborn; Infant, Newborn, Diseases; Metabolism, Inborn Errors; Lipid Metabolism, Inborn Errors; Hypercholesterolemia; Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias; Metabolic Diseases; Lipid Metabolism Disorders
Intervention: mipomersen sodium
Intervention description: 200 mg/ml, in 1 ml solution for subcutaneous injection.
Intervention MeSH terms: Mipomersen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Familial Hypercholesterolemia; Heterozygous Familial Hypercholesterolemia; Homozygous Familial Hypercholesterolemia; ISIS 301012; mipomersen; Open Label Extension

Summary:

      The purpose of this study is to evaluate the safety and efficacy of extended dosing of
      mipomersen in patients with familial hypercholesterolemia on lipid-lowering therapy who have
      completed either the 301012-CS8 (NCT00280995) or 301012-CS9 (NCT00281008) clinical drug
      trials.
    

Eligibility criteria:

        Inclusion Criteria:

        - Satisfactory completion of dosing and Week 7 or Week 15 assessments (depending on the
        treatment and dose received) in their initial study (Protocol 301012-CS8 (NCT00280995) or
        301012-CS9 (NCT00281008)).

        Exclusion Criteria:

        - Have a new condition or worsening of existing condition which in the opinion of the
        Investigator would make the patient unsuitable for enrollment, or could interfere with
        patient's participation in or completion of the study.
Results of Tc99m-Maraciclatide Scintigraphy in Subjects With Diabetes Mellitus and Heart Failure With Preserved Left Ventricular Ejection Fraction
Condition: Diabetes Mellitus; Heart Failure
MeSH terms: Heart Failure; Diabetes Mellitus
Intervention: Tc99m-Maraciclatide
Intervention description: Freeze-dried powder Kit for the preparation of Maraciclatide (99mTc) Injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: CE-MRI - Contrast-enhanced magnetic resonance imaging; DM - Diabetes mellitus; EKG - Echocardiography; HFPEF - Heart failure preserved left ventricular ejection fraction; LVEF - Left Ventricular Ejection Fraction

Summary:

      The purpose of this study is to evaluate the results of 99mTc maraciclatide scintigraphy in
      diabetic subjects with HFPEF. A maximum of 20 subjects with Diabetes Mellitus (DM) and Heart
      Failure With Preserved Left Ventricular Ejection Fraction (HFPEF) will be enrolled and imaged
      with 99mTc maraciclatide. In addition, a maximum of 10 subjects with DM and diastolic
      dysfunction but no diagnosis of heart failure (HF) will be enrolled and imaged with
      99mTc-maraciclatide.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject is between 18 and 80 years of age.

          -  The subject was diagnosed with DM type 2 based upon accepted clinical criteria and
             currently takes at least one diabetes medication.

          -  For HF subjects: The subject was diagnosed with HF with preserved EF within the
             previous 1 year, at which time LVEF was determined to be ≥45%.

          -  For comparison subjects: The subject was determined to have diastolic dysfunction on
             EKG within the previous year and currently has no signs or symptoms of HF.

          -  The subject has been clinically stable for at least 7 days prior to the study imaging
             procedures (e.g., not experiencing continuing chest pain, hemodynamic instability,
             worsening HF symptoms, or clinically significant arrhythmia).

        Exclusion Criteria:

          -  The subject had an acute myocardial infarction within the past 30 days.

          -  The subject had a cardiac revascularization (e.g., percutaneous transluminal coronary
             angiography [PTCA], percutaneous coronary intervention (PCI), or coronary artery
             bypass graft [CABG]) within the past 30 days.

          -  The subject has severe renal dysfunction.

          -  The subject is claustrophobic or has a movement disorder that prevents him/her from
             lying still in a supine position for up to 20 minutes at a time.

          -  The subject has participated in a research study using ionizing radiation in the
             previous 12 months.
The Long-term Safety and Efficacy of CDP6038 (Olokizumab) With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: CDP6038 (olokizumab)
Intervention description: Biological/Vaccine: CDP6038 (olokizumab) 100 mg/mL solution for subcutaneous (sc) injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: RA0089 is a single arm study, however, analysis will also be performed according to the original treatment arms of the parent study NCT01463059 (RA0083).
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; Monoclonal antibody; Interleukin-6; Olokizumab; CDP6038

Summary:

      The purpose of this study is to evaluate the long-term safety and tolerability of CDP6038
      (olokizumab) treatment in adult subjects with active rheumatoid arthritis (RA) who completed
      study RA0083 [NCT01463059].
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed the RA0083 [NCT01463059] study (Week 12 Visit)

          -  Must have maintained their stable dose (and route) of methotrexate (MTX) between 6 to
             16 mg/week in Japan or 7.5 to 20 mg/week in Korea and Taiwan in RA0083 [NCT01463059],
             and plan to maintain this same dose and route of administration for at least 12 weeks

          -  Female subjects must be either postmenopausal for at least 1 year, surgically
             incapable of childbearing, or effectively practicing 2 acceptable methods of
             contraception

        Exclusion Criteria:

          -  Have an ongoing SAE from the RA0083 [NCT01463059] study

          -  Female subjects who are breast-feeding, pregnant, or plan to become pregnant during
             the study or within 24 weeks

          -  Have evidence of active or latent tuberculosis (TB)

          -  Subject is receiving any biologic response modifier or synthetic disease-modifying
             antirheumatic drug (DMARD) other than MTX

          -  Subject has planned surgery during the first 12 weeks of the study

          -  Subjects who tested positive for hepatitis B core antibody (HBcAb) and/or hepatitis B
             surface antibody (HBsAb) at Screening in RA0083 [NCT01463059] and who subsequently
             test positive for hepatitis B virus deoxyribonucleic acid (HBV DNA) at Week 12 of
             RA0083 [NCT01463059]
SI-613 Study for Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: SI-613; Placebo
Intervention description: SI-613 will be repeated intra-articularly administered.; Placebo will be repeated intra-articularly administered.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Knee; Osteoarthritis; Intra-articular injection

Summary:

      The objective of the study is to evaluate the efficacy and safety of intra-articular
      injections of SI-613 compared with placebo for knee OA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provides their written informed consent.

          -  Has a diagnosis at the time of screening of OA of the knee according to American
             College of Rheumatology (ACR) criteria

          -  Is willing to switch to using acetaminophen as a rescue medication

        Exclusion Criteria:

          -  Has a body mass index (BMI) greater than or equal to 40 kg/m2 at screening.

          -  Secondary OA

          -  Is a female subject who is pregnant or lactating.

          -  Is currently hospitalized or has a planned hospitalization during the life of the
             study.
IdeS in Asymptomatic Antibody-Mediated Thrombotic Thrombocytopenic Purpura (TTP) Patients
Condition: Purpura, Thrombotic Thrombocytopenic
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombotic Thrombocytopenic
Intervention: IdeS (0.25 mg/kg); IdeS (0.50 mg/kg)
Intervention description: Single i.v. infusion of IdeS (0.25 mg/kg). Following an evaluation of efficacy and safety in the first 3 patients the dose may be increased in the following 3 patients to 0.5 mg/kg.; Single i.v. infusion of IdeS (0.50 mg/kg).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Asymptomatic antibody-mediated TTP

Summary:

      The main purpose of this study is to evaluate safety and tolerability in patients diagnosed
      with asymptomatic antibody-mediated TTP with low ADAMTS13 activity after receiving single
      intravenous dose of IdeS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years or above

          -  Diagnosed with acquired TTP with ADAMTS13 levels of ≤ 10 % in clinical remission and
             with measurable or previously confirmed ADAMTS13 antibodies

        Exclusion Criteria:

          -  Prior malignancy within 5 years

          -  Test positive for serum hepatitis B surface antigen, hepatitis C antibody and human
             immunodeficiency virus (HIV)

          -  Ongoing infectious disease including P-CRP >10

          -  Test positive for IgE antibodies against IdeS

          -  Secondary cause of TTP

          -  Rituximab treatment or other antibody-based therapy within 7 days prior to IdeS dosing

          -  Treatment with investigational medicinal product within the last 12 weeks proceeding
             screening

          -  Severe other conditions requiring treatment and close monitoring, e.g. cardiac failure
             > NYHA (New York Heart Association) grade 3, unstable coronary disease or oxygen
             dependent COPD

          -  History of any other clinically significant disease or disorder which may either put
             the patient at increased risk because of participation in the study, or influence the
             results or the patient's ability to participate in the study

          -  Hypogammaglobulinemia defined as any values of P-total IgG less than 3 g/L

          -  History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, or
             history of hypersensitivity to drugs with a similar chemical structure or class to
             IdeS (e. g. streptokinase and/or staphylokinase)

          -  Substance abuse or other concurrent medical condition that could confound study
             interpretation or affect the patient's ability to tolerate or complete the study

          -  Breast feeding women or women with a positive pregnancy test

          -  Previously received IdeS treatment
Robotic-Assisted Laparoscopic Extended Pelvic Lymph Node Dissection for Transitional Cell Carcinoma of the Bladder
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms; Carcinoma, Transitional Cell
Intervention: Robotic-assisted laparoscopic surgery
Intervention description: During radical cystectomy, robotic-assisted technique used to perform cystectomy and pelvic lymph node dissections. Each patient will undergo a second-look open lymph node dissection once the incision is made at the end for the urinary diversion.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Healthy volunteers: No
Keywords: Robotic-assisted laparoscopic surgery; Extended pelvic lymph node dissection; RA-PLND; Second-look open lymph node dissection; O-PLND; Radical Cystectomy; Urinary diversion; Bladder

Summary:

      The goal of this clinical research study is to evaluate how many lymph nodes are left behind
      after robotic-assisted removal and are then found after a wider incision is made, in patients
      who are having their bladder removed for the treatment of bladder cancer.

      The primary objective is to compare the lymph node yield achieved by performing a
      robotic-assisted laparoscopic extended pelvic lymph node dissection (RA-PLND) compared to a
      second-look open lymph node dissection (O-PLND) among patients undergoing radical cystectomy
      for transitional cell carcinoma of the bladder.

      The secondary objectives will be to collect prospective outcomes data related to the
      performance of RA-PLND and robotic-assisted cystectomy (RA-C) including operative times,
      estimated blood loss, transfusions, complications, return to diet, utilization of pain
      medication, hospital length, return to regular activities.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients who are eligible for a radical cystectomy and who, in the opinion of the
             treating MDACC physician, are candidates for a robotic-assisted laparoscopic technique
             for management of the bladder and lymph nodes.

          2. Diagnosis of transitional cell carcinoma of the bladder.

          3. Medical fitness for open radical cystectomy by consensus of MDACC urology and
             anesthesia faculty (medicine/cardiology clearance by common best practice criteria).

          4. Staging inclusion by cystoscopic biopsy and bimanual examination under anesthesia:
             carcinoma in-situ, T1, T2.

        Exclusion Criteria:

          1. Prior pelvic radiation.

          2. Morbid obesity, i.e., body mass index (BMI)> 35.

          3. Metastatic disease, bulky disease--T3a/b, prostatic stromal invasion.

          4. Non-transitional cell histology.
Pre-Surgical Study: Effect of Metformin on Breast Cancer Proliferation
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Metformin
Intervention description: 1500 mg per day, divided 500 mg in the morning and 1000 mg in the evening, for at least two weeks prior to surgery
Intervention MeSH terms: Metformin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: Female
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Breast Cancer; Metformin

Summary:

      The purpose of this pilot study is to use a pre surgical intervention model to evaluate the
      biologic effects of metformin in women with newly diagnosed early invasive breast cancer.
      Metformin is a drug commonly used to treat patients with diabetes. This model will be used to
      evaluate the effects of metformin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically-confirmed operable invasive breast cancer or ductal carcinoma in situ
             (DCIS) who undergo core needle biopsy followed by surgical excision at least 2 weeks
             after enrollment

          -  Body mass index > 25

          -  Age ≥ 21 years

          -  No prior chemotherapy, radiation therapy, or surgery within 6 months of study entry

          -  Signed informed consent

        Exclusion Criteria:

          -  History of diabetes mellitus requiring medical therapy

          -  Treatment with other investigational drugs within 6 months of study entry

          -  Significant renal impairment with a creatinine > 1.4 mg/dl

          -  Other serious intercurrent medical illness
A Study to Evaluate the Pharmacokinetic Profile (How the Body Absorbs, Distributes, Metabolizes and Eliminates a Drug) of TMC125 Plus Tenofovir/Emtricitabine Once Daily With or Without Darunavir/r Once Daily in Antiretroviral (ARV) Naive HIV-1 Patients (Patients Have Never Received ARV Treatment).
Condition: HIV-1 Infection
Intervention: TMC125; darunavir; ritonavir
Intervention description: TMC125 400mg once daily for 4 weeks; Darunavir-800mg once daily for 48 weeks; Ritonavir-100mg once daily for 48 weeks
Intervention MeSH terms: Ritonavir; Darunavir; Etravirine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV; AIDS; Immunodeficiency Virus, Human; PREZISTA; darunavir; TMC114; TMC125; Protease Inhibitor; Non-Nucleoside Reverse Transcriptase Inhibitor; Truvada; Treatment Naive

Summary:

      The purpose of this study is to determine the pharmacokinetic profile of TMC125 400mg with
      tenofovir DF/emtricitabine FDC (fixed dose combination) 300/200mg all dosed once daily with
      and without darunavir/ritonavir 800/100 mg once daily in HIV-1 infected, antiretroviral (ARV)
      naÃ-ve patients (patients who have never received ARV treatment).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented HIV-1 infection

          -  Naive to antiretroviral therapy (never received antiretroviral therapy prior to study)

          -  In the opinion of the investigator, have an indication for antiretroviral therapy

          -  Able to comply with the protocol requirements

        Exclusion Criteria:

          -  No previous or current use of antiretroviral medications (ARVs) for the treatment of
             HIV infection or hepatitis B/C infection with anti-HIV activity

          -  No evidence of antiretroviral resistance on current or past resistance assays

          -  No chronic hepatitis B and/or C co-infection

          -  No grade 3 or 4 laboratory abnormality as defined by National Institute of Allergy and
             Infectious Diseases Division of Acquired Immunodeficiency Syndrome (DAIDS) grading
             tables, or a calculated creatinine clearance (CLCr) < 50 mL/min.

          -  No known diabetes mellitus or hyperlipidemia requiring lipid-lowering therapy

          -  No acute viral hepatitis including, but not limited to A, B, or C.