bioihbjkbjnl/mcl2 huggingface dataset:
Evaluating the Effectiveness of Prednisone, Azathioprine, and N-acetylcysteine in Patients With IPF
Condition: Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Idiopathic pulmonary fibrosis (IPF) is a long-term lung disease that affects an individual's
      ability to breathe. In this randomized, double-blind, placebo-controlled trial, we assigned
      patients with idiopathic pulmonary fibrosis who had mild-to-moderate lung-function impairment
      to one of three groups - receiving a combination of prednisone, azathioprine, and NAC
      (combination therapy), NAC alone, or placebo - in a 1:1:1 ratio.
    

Detailed description: 
      IPF is a disease with widespread and permanent scarring of lung tissue which eventually
      results in death. Individuals with IPF may experience breathing difficulties, cough, chest
      pain, and a decreased exercise capacity. Although the cause of IPF is unknown, it may be a
      result of an inflammatory response to an unknown substance. NAC, an antioxidant that is
      effective at loosening up mucus that forms in the lungs, may improve lung function. The
      purpose of this study is to evaluate the effectiveness of NAC at preventing the loss of lung
      function in people with IPF.

      In the initial double-blind, placebo-controlled trial, subjects who have idiopathic pulmonary
      fibrosis with mild-to-moderate impairment in pulmonary function are randomly assigned to
      receive a three-drug regimen of prednisone, azathioprine, and acetylcysteine; acetylcysteine
      alone; or placebo.

      After safety concerns were identified by the data and safety monitoring board, the three-drug
      regimen was stopped by the National Heart, Lung, and Blood Institute (NHLBI) on October 14,
      2011, and a clinical alert was issued. After a brief period of interruption for modification
      of the protocol and approval by the institutional review boards, patients continued to be
      recruited for the acetylcysteine group and the placebo group and were followed for the
      pre-specified duration of 60 weeks.

      Study visits will occur at baseline and Weeks 4, 15, 30, 45, and 60. At all study visits, a
      physical exam and blood collection will occur. At selected visits, the following study
      procedures will occur: lung function testing; urine collection; a 6-minute walk test, and
      questionnaires to assess health status, breathing, and quality of life. Participants will
      record medication usage and symptoms in a daily diary.
    

Intervention name(s): N-acetylcysteine (NAC); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive 600 mg of NAC three times a day.; Participants will receive placebo each day.
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Idiopathic Pulmonary Fibrosis; Prednisone; Azathioprine; NAC; N-acetylcysteine
FFA Hypertension and Inflammation in Lean and Obese Subjects
Condition: Diabetes; Hypertension; Obesity
MeSH terms: Hypertension; Inflammation
Study type: Interventional

Summary: 
      Although a large number of obese patients develop high blood pressure, the cause is unknown.
      The purpose of this study is to look at the effect of high fatty acids (a type of fat) in the
      development of high blood pressure in obese people.
    

Detailed description: 
      Recent studies indicate that increased levels of a circulating fat (free fatty acids or FFAs)
      increases blood pressure, impairs endothelial (vascular) function, and increases inflammatory
      markers in subjects with and without diabetes. The effects of FFA on blood pressure and
      vasculature have not been fully investigated. A group of 12 obese nondiabetic, normotensive
      subjects will be admitted to the Grady Clinical Research Center (GCRC) on separate 4
      occasions. Research subjects will receive, in random order, a 8-hour intravenous (IV)
      infusion of Intralipid 20% at 40 mL/h (a fat solution), 8-hour IV infusion of normal saline
      at 40 mL/h, 8-hour IV infusion of dextrose (sugar) 10% at 40 mL/h, and a 8-hour intravenous
      (IV) infusion combination of Intralipid 20% and dextrose 10% at 40mL/h.
    

Intervention name(s): Intralipid 20%; Normal Saline; Oral fat load
Intervention type(s): Other; Other; Other
Intervention description(s): Lean and obese normotensive subjects will receive Intralipid 20% infusion. Intralipid is an oil-in-water emulsion derived from egg phospholipids, soybean, and glycerol. The Intralipid 20% long-chain triglyceride emulsion contains: 200 g of soy bean oil; 12 g of egg yolk; 25 g of glycerol. The emulsion is composed of the following free fatty acids (FFAs): linoleic acid: 50%, oleic acid: 26%, palmitic acid: 10%, stearic acid: 9%, egg yolk, phospholipids: 3.5% It will be given intravenously at 20 ml/hr (96 g/24 h) for 24 hours.; Lean and obese normotensive subjects will receive normal saline at 20 ml/hr for 24 hours.; Lean and obese normotensive subjects will receive an oral fat load at 96 g/24hr. The oral liquid fat load will be given in equal amounts (16 g) every 4 hours (total 96 g over 24 hours).
Intervention MeSH terms: Soybean oil, phospholipid emulsion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Food Effect and Bioequivalence Study of Simufilam Tablets in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare the pharmacokinetics of the Phase 3 simufilam 100 mg oral tablet when
      taken fasted versus following a high-fat or low-fat meal. Additionally, the Phase 3 oral
      tablet will be compared to the Phase 2 oral tablet for bioequivalence under fasted
      conditions.
    

Detailed description: 
      This is a single-center, randomized, four-treatment, four-sequence crossover study in healthy
      volunteers to estimate the effect of food on the pharmacokinetics of simufilam following oral
      100 mg Phase 3 oral tablets. Additionally, the relative bioavailability of the Phase 3 100 mg
      tablet will be compared to the earlier Phase 2 100 mg tablet in the fasted state. A total of
      twenty four (24) healthy volunteers (12 male and 12 female) will be enrolled into this study.
      Subjects will be randomly assigned to one of four treatment sequences (6 subjects/sequence).
    

Intervention name(s): simufilam
Intervention type(s): Drug
Intervention description(s): Simufilam 100 mg oral tablets: the Phase 3 oral tablet for the first 3 arms and the Phase 2 tablet for the 4th arm.
Other intervention name(s): PTI-125
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Four-way crossover of Phase 3 tablets under fasted or high-fat or low-fat conditions and the Phase 2 tablet under fasted conditions. Subjects are randomized to a sequence.
Masking: None (Open Label)
Primary purpose: Other
Pharmacokinetics of Leptin Administration During Fasting
Condition: Energy Deficiency Due to Short-term Fasting
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study will be to determine the correct dose of leptin, a natural hormone
      secreted by the fat cells, to give to people when they are fasting and also to determine
      whether giving leptin to a person when he or she is fasting will reverse the changes in
      hormone levels that occur with fasting.
    

Detailed description: 
      Leptin is a newly-identified hormone secreted by fat cells under normal conditions that acts
      in the brain to decrease appetite and increase long term energy usage. Leptin levels usually
      go down when people are not eating for extended periods of time. Changes in metabolism and
      certain hormone levels also occur with fasting. By studying the pharmacokinetics of leptin
      administration, we can evaluate the changes of leptin levels in response to giving different
      doses of leptin as well as acute changes of other hormones in response to leptin levels.
      Investigations such as this one have important implications for the future therapeutic use of
      leptin, including determining the appropriate dose of leptin to use in future studies
      involving leptin administration.

      Comparison: subjects receiving leptin at 3 different doses in the fed state compared to the
      fasting state
    

Intervention name(s): r-metHuLeptin
Intervention type(s): Drug
Intervention description(s): r-metreleptin was given in 3 different dose in fed and fasting states
Other intervention name(s): Recombinant leptin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: leptin; fasting; pharmacokinetics
HD11 for Intermediate Stages
Condition: Hodgkin´s Lymphoma
MeSH terms: Hodgkin Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to (1) compare the efficacy of the BEACOPP regimen with that of ABVD
      as a 4-cycle chemotherapy combined with an involved field irradiation and (2) to define the
      optimum radiation dose comparing of 30 to 20 Gy in the same context.
    


Intervention name(s): Adriamycin; Bleomycin; Vinblastine; DTIC; Etoposide; Procarbazine; Prednisone; Vincristine; radiation therapy
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Radiation
Intervention description(s): 20 or 30Gy IF-RT
Intervention MeSH terms: Prednisone; Etoposide; Vincristine; Doxorubicin; Liposomal doxorubicin; Bleomycin; Vinblastine; Procarbazine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hodgkin´s lymphoma; intermediate stages
GAIN Trial: Phase 2/3 Study of COR388 in Subjects With Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a randomized, double-blind, placebo-controlled study that assessed the efficacy,
      safety, and tolerability of 2 dose levels of COR388 in subjects with a clinical diagnosis of
      mild to moderate Alzheimer's disease (AD) dementia.
    

Detailed description: 
      This was a randomized, double-blind, placebo-controlled study that assessed the efficacy,
      safety, and tolerability of 2 dose levels of COR388 oral capsules in subjects with probable
      Alzheimer's disease (AD) dementia according to the National Institute on Aging-Alzheimer's
      Association (NIA-AA) criteria. The subject did not have other conditions or brain imaging
      abnormalities that could explain the symptoms of dementia. All subjects were encouraged to
      have lumbar punctures (LPs) (during screening, week 24 and week 48) in the absence of medical
      conditions that could increase the risk of the procedure in the opinion of the Investigator.
      Cerebrospinal fluid (CSF), saliva, and blood were analyzed for measurements of biomarkers of
      AD and neuroinflammation, and for the presence of bacterial deoxyribonucleic acid (DNA) of
      Porphyromonas gingivalis (P. gingivalis). A subset of sites monitored subjects for clinical
      evidence of periodontitis at baseline, 24 and 48 weeks.

      The study consisted of 3 phases: a screening phase of up to 6 weeks, a treatment phase of up
      to 48 weeks, and a safety follow-up phase of 6 weeks.
    

Intervention name(s): COR388 capsule; Placebo capsule
Intervention type(s): Drug; Drug
Intervention description(s): BID (twice daily); BID
Other intervention name(s): atuzaginstat; atuzaginstat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Subarachnoidal Anesthesia: Dexmedetomidine vs Fentanyl Plus Hyperbaric Bupivacaine for Lower Abdomen Surgery
Condition: Dexmedetomidine in Subarachnoidal Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      Dexmedetomidine, highly selective agonist for alpha-2 receptors, enhances the sensory and
      motor block with prolonged postoperative analgesia without hemodynamic compromise.

      OBJECTIVE: To evaluate effects of dexmedetomidine vs fentanyl with hyperbaric bupivacaine
      spinal anesthesia for lower abdominal surgeries.

      METHODS: double-blind, randomized, American Society Anesthesiologist classification (ASA) : I
      - II, 18-65 years. F group (23 patients) received 25 mcg fentanyl, Group D (27 patients), 10
      mcg dexmedetomidine with 12.5 mg hyperbaric bupivacaine . 0,02mgrs morphine / kg
      intravenously if EVA≥4was administered in postoperative period. Hemodynamic variables and O2
      saturation intraoperatively was recorded, EVA every 4 hours, side effects, sensory block,
      motor, sedation and peripheral neurological manifestations of toxicity.
    


Intervention name(s): Dexmedetomidine and bupivacaine; Fentanyl and bupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): 10 micrograms of dexmedetomidine plus 12,5 mgrs of bupivacaine subarachnoideal; 25 micrograms of fentanyl plus 12,5 mgrs of bupivacaine subaracnoideal
Intervention MeSH terms: Fentanyl; Dexmedetomidine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparison of Antimicrobial Coated Ureteral Stents With Non-coated Stents
Condition: Quality of Life
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will be conducted to compare the efficacy of antimicrobial coated ureteral stent
      with non-coated stents in prevention of UTI in patients with ureteral stents
    

Detailed description: 
      The efficacy of antimicrobial coated of ureteral stent with silver sulphadiazine in
      prevention of UTI in patients with ureteral stents will be studied by comparining the results
      of urine and stent cultures with patients who had non-coated ureteral stents. The impact of
      antimicrobeal stent coating on patients' quality of life will be evaluated with comparing the
      scores of ureteral stent symptom questionnaire between both groups.
    

Intervention name(s): Antimicrobeal coated stents
Intervention type(s): Device
Intervention description(s): Patients in the intervention arm will undergo placement of (Silver Sulphdiazine) antimicrobeal coated stents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Ureteral stents; Double J stent; Antimicoreal coated stent; USSQ; UTI
Comparative Bioavailability Study of Synerx and Verelan PM 300 mg Verapamil HCl ER Capsules Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the bioequivalency of Synerx Pharma Verapamil
      extended release capsules.
    

Detailed description: 
      The purpose of this study is to determine if Synerx Pharma Verapamil HCl ER Capsules are
      bioequivalent to Verelan PM capsules in healthy volunteers under food effect conditions.
    

Intervention name(s): verapamil controlled release
Intervention type(s): Drug
Intervention description(s): verapamil 300 mg controlled release capsule as a single dose
Other intervention name(s): Verelan PM; verapamil controlled release capsule
Intervention MeSH terms: Verapamil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Central and Peripheral Adiposity and Iron Absorption
Condition: Adiposity; Iron-deficiency
MeSH terms: Iron Deficiencies; Obesity
Study type: Interventional

Summary: 
      Adiposity is a state of sub-clinical inflammation, thus hepcidin is increased in adiposity,
      often leading to iron deficiency in this population group. Central adiposity is generally
      considered having a greater negative effect on health compared to peripheral adiposity.
      Whether this can be also seen in hepcidin and thereby in iron absorption is uncertain.
    


Intervention name(s): Stable iron isotopes
Intervention type(s): Other
Intervention description(s): Participants have to consume a test meal containing stable iron isotopes in order to determine iron absorption
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Prediction of Relapse Risk in Stable Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic; Recurrence
Study type: Interventional

Summary: 
      Whether and when systemic lupus erythematosus (SLE) patients with stable disease should
      withdraw glucocorticoid (GC)? How about the relapse risk? What are the risk factors for
      disease flare? All the above are unclear. Long-course GC treatment has a lot of side-effects
      even in a sustaining low dose. The aim of this study is to explore the relapse risk after GC
      withdrawal in SLE patients with stable disease more than one year and to establish a
      predictive model for flare risk stratification.
    

Detailed description: 
      Systemic lupus erythematosus (SLE) is a chronic autoimmune disease with a relapsing-remitting
      course. For patients in remission, glucocorticoid (GC) is used to be maintained in a low dose
      for a long time in fear of disease flare. Long-term GC could bring a lot of side-effects even
      in a low dose. Whether and when patients with stable disease should withdraw GC? How about
      the relapse risk? What are the risk factors for disease flare? All the above remain unclear.
      The aim of this study is to explore the relapse risk after GC withdrawal in SLE patients with
      stable disease and to establish a predictive model for risk stratification. Meanwhile the
      investigators aim to testify the effects of hydroxychloroquine in preventing SLE relapse.
      This study is an open-labeled randomized controlled clinical trial.
    

Intervention name(s): Drug free; HCQ; GC+HCQ
Intervention type(s): Other; Drug; Drug
Intervention description(s): Both Glucocorticoid(GC) and hydroxychloroquine(HCQ) treatment are stopped in stable SLE patients.; Glucocorticoid(GC) treatment is stopped in stable SLE patients. Hydroxychloroquine (HCQ) is kept as 0.2-0.4g/d; Glucocorticoid(GC) is kept no more than 7.5mg/d. Hydroxychloroquine (HCQ) is kept as 0.2-0.4g/d.
Other intervention name(s): Hydroxychloroquine; Hydroxychloroquine; Glucocorticoid
Intervention MeSH terms: Hydroxychloroquine; Glucocorticoids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Systemic Lupus Erythematosus; Stable; Relapse Risk; Glucocorticoid Withdrawal
Effect of Prophylactic Antibiotics on Intra-Operative Culture Results
Condition: Infection; Arthroplasty
MeSH terms: Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Subjects will be consented and then determined randomly whether they will receive antibiotics
      prior to their surgery or during their surgery. Each patient will have cultures taken before
      and during their surgery from the infected hip or knee. Results will be compared after
      completion of the study.
    

Detailed description: 
      It is unknown whether giving pre-operative antibiotics affects the results of intraoperative
      bacterial cultures. This is an important question as antibiotics are often not given prior to
      surgery out of concern that accurate culture results will not be obtained. It is important to
      obtain accurate cultures so that targeted antibiotic therapy can be used. However, delaying
      the administration of antibiotics also delays the onset of treatment. Currently, the optimal
      course of action is unknown. The purpose of this study is to resolve this issue and determine
      if prophylactic antibiotics affect intra-operative culture results in patients undergoing
      revision hip or knee arthroplasty surgery for infection.

      This is a prospective randomized clinical study to determine if prophylactic antibiotics
      affect intra-operative culture results in patients undergoing revision hip or knee
      arthroplasty surgery for infection. Pre-operatively, patients will have their affected joint
      aspirated and this fluid will be sent for cultures. Patients are then randomized to receive
      prophylactic antibiotics (Vancomycin and Ancef) within one hour prior to surgery or to have
      pre-operative antibiotics withheld. Every patient then has their affected joint cultured
      intra-operatively. All samples will be evaluated for the presence of aerobic bacteria,
      anaerobic bacteria, mycobacteria, and fungus. Pre-operative and post-operative cultures in
      both study populations are compared to determine the effects of pre-operative antibiotics.
    

Intervention name(s): Prophylactic Antibiotics; Control Antibiotics
Intervention type(s): Procedure; Procedure
Intervention description(s): Preoperative Antibiotics; Antibiotics will be held until intraoperative cultures have been obtained.
Other intervention name(s): Revision; Arthroplasty; Infection; Antibiotics; Ancef; Vancomycin; Arthroplasty; Infection; Antibiotics
Intervention MeSH terms: Anti-Bacterial Agents; Vancomycin; Antibiotics, Antitubercular
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: revision; infection; knee; hip; replacement; antibiotics
Antimicrobial Susceptibility Patterns of N. Gonorrhea Isolates in an Era of Quinolone Resistance
Condition: Gonorrhea
MeSH terms: Gonorrhea; Disease Susceptibility
Study type: Observational

Summary: 
      To perform a laboratory sensitivity testing survey of antibiotic agents against Neisseria
      gonorrhea isolates from men with symptomatic urethritis seen at an STD clinic.
    

Detailed description: 
      Until recently, the fluoroquinolones (ofloxacin, ciprofloxacin, levofloxacin) have been the
      first line oral agents for the empiric treatment of gonorrhea. The prevalence of quinolone
      resistant Neisseria gonorrheae (QRNG) has been rising since 2000. In 2006, the CDC updated
      its guidelines to include recommendations against the use of quinolones for treatment of
      Neisseria gonorrheae. Ceftriaxone (available only by intravenous or intramuscular route) was
      named as the first line treatment for urogenital and pharyngeal disease. Availability, in the
      United States, of the other two CDC recommended agents cefixime (oral) and spectinomycin (IM)
      has been nonexistent.

      At this time, there is little data on the in-vitro (laboratory test) susceptibility of
      antibiotics against gonorrhea, particularly oral drugs. The purpose of this study is to
      collect specimens of gonorrhea in a non-invasive swab manner from men with symptomatic
      urethral discharges for laboratory sensitivity testing against a wide array of antibiotic
      agents.

      Specific Aims:

      To perform a laboratory sensitivity testing survey of antibiotic agents against Neisseria
      gonorrhea isolates from men with symptomatic urethritis seen at a Duval County STD clinic .
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male patients seen in the Duval County Sexually Transmitted Diseases Clinic with smears
        positive for gram negative diplococci or unexplained pyuria
      
Biospecimen description: 
      Urethral discharge for Neisseria gonorrheae culture
    
Keywords: Neisseria gonorrheae; Antimicrobial Susceptibility; Quinolone Resistance; Sexually transmitted diseases