bioihbjkbjnl/mcl2 huggingface dataset:
Serum Tenascin-C Concentration in Patients With Acute Coronary Syndrome
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Observational [Patient Registry]

Summary: 
      This study valuates the serum Tenascin-C concentration in patients with acute coronary
      syndrome.
    

Detailed description: 
      It is found that Tenascin-C plays an important role in ventricular remodeling, heart failure,
      aortic dissection, rheumatic heart disease and other cardiovascular diseases, which may be a
      new marker for the diagnosis and prognosis prediction of these diseases. However, there is
      few relevant studies about the Tenascin-C concentration in patients with acute coronary
      syndrome.This study valuates the serum Tenascin-C concentration in patients with acute
      coronary syndrome.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients with acute coronary syndrome,including STEMI,non-STEMI,and UAP patients.
      
Keywords: Tenascin-C
A Study in Healthy Men to Test How BI 474121 is Tolerated
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety, tolerability, and pharmacokinetics of BI 474121 will be assessed in healthy Japanese
      male using single rising oral doses in order to provide the basis for an ongoing clinical
      development of BI 474121 for the treatment of cognitive impairment in patients with
      Alzheimer's Disease and schizophrenia.
    


Intervention name(s): BI 474121; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BI 474121; Placebo matching BI 474121
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Safety and Effectiveness of Isoprinosine in Patients With Weakened Immune Systems and Lymph Node Disease
Condition: Lymphatic Disease; HIV Infections
MeSH terms: Lymphatic Diseases
Study type: Interventional

Summary: 
      The objective of this Phase III, randomized, double-blind, placebo-controlled study in
      patients with immunologic deficiency is to determine the effect of Isoprinosine in producing
      an immuno-restorative response within the study observation period (including the 2-month
      period following cessation of the 28 days of treatment), measured by one or more of the
      following immunological parameters:

        -  Increase in natural killer (NK) cell activity.

        -  Increase in total T-cells (OKT-11).

        -  Increases in absolute number and percentage of T-helper cells (OKT-4).
    


Intervention name(s): Inosine pranobex
Intervention type(s): Drug
Intervention MeSH terms: Inosine Pranobex
Masking: Double
Primary purpose: Treatment
Keywords: T-Lymphocytes; Immune Tolerance; Inosine Pranobex; Killer Cells; T-Lymphocytes, Helper-Inducer; Acquired Immunodeficiency Syndrome; AIDS-Related Complex
FG-4592 for Treatment of Anemia in Subjects With Chronic Kidney Disease Not on Dialysis
Condition: Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, multicenter, double-blind, placebo-controlled study of the treatment of
      anemia in subjects with CKD not on dialysis, with treatment up to 52 weeks.
    

Detailed description: 
      This is a randomized, multicenter, double-blind, placebo-controlled study of the treatment of
      anemia in subjects with CKD not on dialysis.

      Eligible subjects are randomized to FG-4592 or placebo at a ratio of 2:1. The primary
      endpoint is change in Hb from baseline to the average level during Weeks 7 to 9 inclusive.
    

Intervention name(s): FG-4592; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Kidney Disease
Study to Evaluate the Safety Tolerability and Acceptability of Long Acting Injections of the Human Immunodeficiency Virus (HIV) Integrase Inhibitor, GSK1265744, in HIV Uninfected Men (ECLAIR)
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a Phase IIa, randomized, multi-site, two-arm, double-blinded study to evaluate
      the safety, tolerability, and acceptability of GSK1265744 long acting injectable formulation
      (744 LA) in adult male subjects. To evaluate the safety and tolerability of the injectable
      agent, 744 LA (800 milligrams (mg) dose administered at three time points at 12 week
      intervals) through Week 41 in HIV-uninfected men. Eligible participants will be randomized in
      a 5:1 ratio to receive 744 LA or matching placebo. Participants will receive daily oral 744
      (30 mg tablets) or matching placebo for 4 weeks during the Oral Phase of the study, followed
      by a one week washout period. Following safety lab assessments from the Oral Phase,
      participants will enter the Injection Phase and receive Intramuscular (IM) injections of 744
      LA or placebo at three time points at 12 week intervals. IM injections will consist of 800 mg
      of 744 or a matching control
    


Intervention name(s): 744 Tablet; 744 LA Injection; Placebo Tablet; Placebo Injection
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): White to almost white oval shaped film coated 30 mg tablets for oral administration; Sterile white to slightly coloured suspension containing 200 mg/mL of 744 as free acid for administration by intramuscular (IM) injection; Microcrystalline cellulose, Opadry film-coating, white OY-S-28876; Sterile saline 0.9% Sodium Chloride Injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pre-Exposure Prophylaxis; HIV integrase; Intramuscular Injection; GSK1265744
Enzalutamide and Hormone Therapy Before, During, and After Radiation for High Risk Localized Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is being done to find out whether combining two FDA approved drugs along with
      radiation therapy for the treatment of high risk localized prostate cancer is safe and well
      tolerated.
    

Detailed description: 
      -  this pilot study will assess the safety and tolerability of combining enzalutamide with
           an gonadotropin-releasing hormone agonist (GnRH) and external beam radiation

        -  Correlative imaging and tissue biopsy analysis will be performed to assess the
           radiographic response to enzalutamide plus gonadotropin-releasing hormone agonist (GnRH)
           therapy as well as intratumoral androgen signaling
    

Intervention name(s): Enzalutamide; Leuprolide acetate; radiation
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): 160mg by mouth each day; 22.5 mg intramuscular every 3 months or 45mg intramuscular every 6 months; External beam radiation will be delivered as per standard radiation therapy protocol
Other intervention name(s): Xtandi; Lupron
Intervention MeSH terms: Leuprolide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: prostate cancer, enzalutamide, radiation, hormone therapy
EAGLE: Evaluating Genotypes Using Intravitreal Aflibercept Injection
Condition: Macular Degeneration; Wet Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Study type: Interventional
Phase: Phase 4

Summary: 
      Clinical and genetic evaluation of individuals treated with intravitreal aflibercept
      injection (Eylea) for neovascular age-related macular degeneration (wet AMD)
    

Detailed description: 
      Clinical and genetic assessment of treatment response in patients with age-related macular
      degeneration using intravitreal aflibercept injection. This study seeks to determine if
      different genetic polymorphisms of vascular endothelial growth factor A (VEGF-A) and HtrA
      serine peptidase 1(HTRA1) and other genes correlate to the response to intravitreal
      aflibercept injection therapy.
    

Intervention name(s): Intravitreal aflibercept injection
Intervention type(s): Drug
Intervention description(s): Intravitreal aflibercept injection 2 mg (0.05 mL) administered every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) intravitreal injection once every 8 weeks(2 months) with the option to treat monthly based on retreatment criteria for a total duration of 12 months.
Other intervention name(s): Eylea
Intervention MeSH terms: Aflibercept
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AMD; Wet AMD; Macular degeneration; Wet macular degeneration; Neovascularization; Retina; Retinal degeneration
Uterine Flushing With Human Chorionic Gonadotrophin and Unexplained Infertility
Condition: Unexplained Infertility
MeSH terms: Infertility; Flushing
Study type: Interventional

Summary: 
      A prospective randomized study included 210 women with Unexplained infertility subjected to
      combined ovarian stimulation and Intrauterine insemination (IUI). Two equal groups. Study
      group, subjected to uterine flushing with Human chorionic gonadotropin (HCG) one day before
      IUI and control group subjected to IUI alone.
    

Detailed description: 
      A prospective randomized study included 210 patients with Unexplained infertility subjected
      to coupled ovarian stimulation and Intrauterine insemination (IUI). Two equal groups. Study
      group, subjected to uterine flushing with Human chorionic gonadotropin (HCG) one day before
      IUI and control group subjected to IUI alone.
    

Intervention name(s): HCG Uterine flushing; IUI; Vaginal flushing with 10 ml normal saline
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): HCG Uterine flushing was done one day before IUI with HCG (500 IU) in 10 ml of saline.; Intrauterine insemination (IUI); Flushing of the vagina with 10 ml of saline
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: intrauterine injection of human chorionic gonadotropin before intrauterine insemination (IUI) compared to IUI alone
Masking: Single (Participant)
Primary purpose: Treatment
The Effect of STIOLTO™ RESPIMAT® on Fatigue in Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether exercise can be prolonged in COPD can by
      the inhaled bronchodilator Stiolto Respimat. The study will identify whether any endurance
      benefit is due to reduction in fatigue that originates within the skeletal muscles and/or
      from effects on neural activation of the skeletal muscles.
    

Detailed description: 
      Patients with chronic obstructive pulmonary disease (COPD) have reduced exercise tolerance.
      One mechanism for this is thought to be due to dynamic hyperinflation during exercise (an
      increase in the end-expiratory lung volume) that contributes to the sensation of
      breathlessness. Whether this also contributes to inhibiting motor recruitment, and reduces
      the available power output (termed performance fatigue; PF), is not well understood.
      Preliminary data suggests that many COPD patients, unlike healthy subjects, stop exercise
      with a 'skeletal muscle power reserve' i.e. the ability to acutely increase muscle power
      output. This suggests that they are limited in the exercise task by mechanisms other than
      acute intramuscular limitations to power production (termed muscle fatigue; MF). Exercise
      tolerance is increased by treatment with the fixed-dose combination bronchodilator, STIOLTO™
      RESPIMAT®. We hypothesize that increased exercise tolerance with STIOLTO™ RESPIMAT® (reduced
      performance fatigue; PF) will be mediated by a combination of: 1) reduced inhibition of
      muscle activation (termed activation fatigue; AF) allowing patients to drive their leg
      muscles harder, and thus; 2) increased muscle fatigue (MF).
    

Intervention name(s): Stiolto Respimat; Placebo Respimat
Intervention type(s): Drug; Drug
Intervention description(s): Oral inhalation spray; Oral inhalation spray
Other intervention name(s): Tiotropium Bromide and Olodaterol
Intervention MeSH terms: Bromides; Tiotropium Bromide; Olodaterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Phase 1 Study of NPT200-11 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability and blood levels of orally
      administered NPT200-11 in healthy subjects. In addition, the maximally tolerated dose will be
      determined.
    


Intervention name(s): NPT200-11; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single doses of NPT200-11capsules, orally administered; Single doses of microcrystalline cellulose capsules, orally administered
Other intervention name(s): Microcrystalline cellulose capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Phase 1; Safety; Tolerability; Pharmacokinetics; Parkinson's Disease
Multiple Dose Study of PF-04991532 in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Metabolic Diseases; Glucose Metabolism Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK),
      and pharmacodynamics (PD) of PF-04991532 following multiple (14 days) escalating oral doses
      in patient wtih type 2 diabetes.
    

Detailed description: 
      Safety/Tolerability, PK, and PD
    

Intervention name(s): PF-04991532; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be dosed wtih PF-04991532 for 14 days. The tentative dosing schedule is 30, 100, 300, 1000, and 1500 mg QD, and 150 and 500 mg BID). Doses shown may be adjusted upwards or downwards and may be adjusted to include intermediate doses. All doses will be administered as tablets (10, 50, and 150 mg strengths). In each cohort 9 subjects will receive PF-04991532 and 3 will receive placebo.; Placebo to match PF-04991532 will be provided. Subjects will be dosed for 14 days. In each cohort 9 subjects will receive PF-04991532 and 3 will receive placebo.
Intervention MeSH terms: 6-(3-cyclopentyl-2-(4-(trifluoromethyl)-1H-imidazol-1-yl)propanamido)nicotinic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: phase 1; safety and tolerability; pharmacokinetics; PK; pharmacodynamics; PD; type 2 diabetes mellitus
Two Cases of Pulmonary Cysticercosis Manifesting as Pleural Effusion: Case Report and Literature Review
Condition: Cysticercosis
MeSH terms: Cysticercosis; Taeniasis; Neurocysticercosis; Pleural Effusion
Study type: Observational

Summary: 
      Isolation lung cysticercosis reports are rare in literature. Most lung lesions were
      characterized by nodules. The investigators access one case which was characterized with
      pulmonary cavity and pleural effusion by Gupta N, et al in 2015 from PUBMED and Medline. But
      pleural effusion and exudative lesions is reported for the first time.
    

Detailed description: 
      Cysticercosis is an important public health problem in developing countries. The major
      involvement sites are the central nervous system and the eyes，although striated muscles and
      subcutaneous tissues are frequently involved in the disseminated form of disease. Pulmonary
      involvement in cysticercosis is very rare and ill-defined nodular shadows distributed
      throughout the lung is the usual radiological presentation. Only one case of cysticercosis
      presenting as lung cavity with pleural effusion has been reported so far in literature. The
      investigators describe two cases in which pleural effusion due to cysticercosis were detected
      on X and CT.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Two patients with pleural effusion presenting with chest tightness and chest pain were
        enrolled in this study with a definitive diagnosis of cysticercosis confirmed by pleural
        effusion examination
      
Keywords: Cysticercosis; pleural effusion; pulmonary
Intraoperative and Postoperative Analgesia for Laparoscopic Surgery.
Condition: Analgesia
MeSH terms: Agnosia
Study type: Interventional
Phase: Phase 4

Summary: 
      Main Hypothesis: laparoscopic surgery is very painful to patient during and after surgery. We
      would like to compare different analgesic methods.
    


Intervention name(s): morphine; intrathecal analgesia (morphine); general anesthesia (fentanyl)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose: 0.1-0.5 mg; 0.1-0.5 mg of morphine; general anesthesia alone
Intervention MeSH terms: Fentanyl; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Laparoscopic surgery (general surgery).
Electromyography of the Pectoral Muscle in Mastalgia Patients
Condition: Mastalgia
MeSH terms: Mastodynia
Study type: Observational

Summary: 
      Mastalgia is a common problem for women. The aim of this study is to investigate the role of
      neuromuscular pathologies of the thorax wall at mastalgia ethiopathogenesis.
    

Detailed description: 
      Mastalgia is a common health problem for women especially these days. Studies demonstrated
      that 48% of the women with mastalgia have serious difficulties in their sexual life, 36% have
      physical activity difficulties, 13% have social activity difficulties and 6% have work or
      school activity difficulties. The etiology of the mastalgia is not clear. Because of the
      women with mastalgia tested out lots of examinations for the etiology. Also this problem has
      financial load because of the unknown etiology.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        31 patients who has unilateral mastalgia
      
Keywords: Mastalgia; electromyography; Pectoral
Flavocoxid, A Plant-Derived Therapy, for the Treatment of Knee Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 1

Summary: 
      Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly prescribed to treat arthritis. The
      purpose of this study is to test the effectiveness of flavocoxid, a plant-derived compound,
      for the treatment of knee osteoarthritis (OA) in adults.

      Study hypotheses: 1) Flavocoxid has an acceptable safety and tolerability profile as
      determined by the Generally Regarded as Safe (GRAS) profile in patients with OA compared to
      identical placebo. 2) Flavocoxid will be more effective as a therapy for OA compared to
      identical placebo.
    

Detailed description: 
      OA is a leading chronic disease in older adults and is characterized by degeneration of
      articular cartilage of the joints in hands, spine, knees, and hips. In joints, tissue injury
      and pain are caused by the conversion of arachidonic acid to such inflammatory compounds as
      cyclooxygenases-1 and -2 (COX-1 and -2) and 5-lipoxygenase (5-LO). Conventional NSAIDs
      inhibit COX-1 and -2, but have little or no effect on 5-LO. NSAIDs provide relief from the
      pain of OA; however, NSAIDS are also associated with significant side effects, including
      gastrointestinal bleeding, venous thrombosis, and nephrotoxicity. Novel alternative therapies
      with increased safety and efficacy with fewer or no side effects are desirable; plant-derived
      substances might be useful alternatives to NSAIDs. Flavocoxid, a botanical extract derived
      from two plants, Scutellaria baicalensis and Acacia catechu, has been shown to inhibit COX-1
      and -2 as well as 5-LO. The purpose of this study is to evaluate the safety and efficacy of
      flavocoxid in relieving the symptoms of knee OA in adults.

      This study will last 12 weeks. Participants will be randomly assigned to one of two groups.
      Group 1 participants will receive daily flavocoxid; Group 2 participants will receive
      placebo. There will be 5 study visits: study entry and Weeks 2, 4, 8, and 12. Joint pain,
      tenderness, and swelling will be assessed at each study visit. A 30-foot timed walking test
      will also be performed at all visits. A physical exam and blood collection will occur at
      study entry and Week 12. Other study assessments will include safety monitoring,
      patient/physician global disease ratings, quality of life measures, depression and anxiety
      ratings, and measures of efficacy as determined by the Western Ontario and McMaster (WOMAC)
      OA index.
    

Intervention name(s): Flavocoxid; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Daily flavocoxid for 12 weeks; Daily placebo for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Medical Food; Botanicals; Phytochemicals