bioihbjkbjnl/mcl2 huggingface dataset:
Optimizing Surgical Conditions During Laparoscopic Herniotomy With Deep Neuromuscular Blockade
Condition: Laparoscopic Herniotomy
Intervention: Rocuronium and Sugammadex
Intervention MeSH terms: Rocuronium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Neuromuscular Blockade; Laparoscopy

Summary:

      The purpose of this study is to investigate surgical work space and surgical conditions in
      patients scheduled for laparoscopic umbilical, -linea alba and incisional herniotomy. The
      patients will act as their own control with evaluation of surgical work space and surgical
      conditions during both deep NMB and no NMB.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients > 18 years old

          -  Elective laparoscopic umbilical herniotomy, incisional herniotomy and linea alba -
             herniotomy

          -  Can read and understand Danish

          -  Informed consent

        Exclusion Criteria:

          -  Known allergy to sugammadex, rocuronium or mivacurium

          -  Known homozygous variants in the butyrylcholinesterase gene

          -  Severe renal disease, defined by S-creatinine> 0.200 mmol/L, GFR < 30ml/min or
             hemodialysis)

          -  Neuromuscular disease that may interfere with neuromuscular data

          -  Lactating or pregnant (Women of child bearing potential must take a urine pregnancy
             test at the day of the operation. The test will be provided by the hospital staff).

          -  Indication for rapid sequence induction
Effect of Risk Factors Likely to Influence Immuno of Combined Hepatitis A & B Vacc vs Monovalent Hepatitis A & B Vacc
Condition: Hepatitis B; Hepatitis A
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: TWINRIX™; Engerix™-B; HAVRIX™; HB VAX PRO™; Vaqta™
Intervention description: Intramuscular injection, 3 doses; Intramuscular injection, 3 doses; Intramuscular injection, 2 doses; Intramuscular injection, 3 doses; Intramuscular injection, 2 doses
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 596.0
Sex: All
Minimum age: 41 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Combined hepatitis A and hepatitis B vaccine; Hepatitis B; Hepatitis A; Monovalent hepatitis A and hepatitis B vaccines

Summary:

      The focus of this study is to evaluate how risk factors like age, gender, body mass index,
      smoking, alcohol consumption, etc. can influence immune response when subjects are vaccinated
      with GSK Biologicals' combined hepatitis A/hepatitis B vaccine or monovalent hepatitis A and
      B vaccines (from GSK Biologicals' or different manufacturers). The Protocol Posting has been
      updated in order to comply with the FDA Amendment Act, Sep 2007.
    

Eligibility criteria:

        Inclusion criteria:

          -  Subjects who the investigator believes that they can and will comply with the
             requirements of the protocol should be enrolled in the study.

          -  Healthy and non-healthy male or female aged 41 years or older at the time of the first
             vaccination.

          -  Written informed consent obtained from the subject.

          -  No serological signs of hepatitis A or B infection at screening.

          -  If the subject is female, she must be of non-childbearing potential or, if of
             childbearing potential, she must be abstinent or have used adequate contraceptive
             precautions for 30 days prior to vaccination, have a negative pregnancy test and must
             agree to continue such precautions for two months after completion of the vaccination
             series.

        Exclusion criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccines within 30 days preceding the first dose of study vaccine, or planned
             use during the study period.

          -  History of any hepatitis A or hepatitis B vaccination or infection, since the primary
             vaccination study 100382.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine.

          -  Acute disease at the time of enrolment. .

          -  Pregnant or lactating female.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions during the primary vaccination period.
Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytely® and Bisacodyl Tablet Bowel Prep Kit for Colon Cleansing
Condition: Colon Cleansing
Intervention: Polyethylene glycol; Oral sodium phosphate solution
Intervention description: HalfLytely and Bisacodyl Tablet Bowel Prep Kit, administered as 1 bisacodyl tablet followed by HalfLytely oral solution in a total liquid volume of approximately 2 L; OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2154.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Colon Cleansing; Bowel Prep; Colonoscopy

Summary:

      The purpose of this study is to compare the safety and efficacy of OsmoPrep tablets versus
      HalfLytely and Bisacodyl Tablet Bowel Prep Kit in subjects who are undergoing colonoscopy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between 18 and 70 years of age, inclusive

          -  Scheduled for colonoscopy within 21 days of the screening visit

          -  Able to swallow tablets the size of a multivitamin without difficulty

        Exclusion Criteria:

          -  History of biopsy-proven acute phosphate nephropathy

          -  Known allergy or hypersensitivity to treatment arms

          -  History of gastric stapling or bypass procedure or history of gastric retention

          -  History of any other sodium phosphate preparation within 6 months prior to colonoscopy
Is 10 Injections of Bladder Botox Less Painful Than 20 Injections?
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: OnabotulinumtoxinA 100 Units
Intervention description: BOTOX for injection is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for:
• Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication.
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 41.0
Sex: Female
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Overactive Bladder; Botox/OnabotulinumtoxinA; Pain; OAB; Non-neurogenic Overactive bladder

Summary:

      The purpose of this research study is to help determine if 10 injections of Botox ® 100 units
      is less painful than 20 injections of Botox ® 100 units based on effectiveness in reducing
      urge incontinence episodes. Study will also be assessed for the pain of procedure and adverse
      outcomes of 20 injections versus 10 injections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female gender

          -  At least 18 years of age

          -  Have already decided to undergo intradetrusor Botox® injections for treatment of
             refractory overactive bladder.

          -  Able and willing to learn clean intermittent catheterization (or care provider is
             willing and able to perform intermittent catheterization).

          -  Understands and is willing to undergo follow up and complete questionnaires as
             described in this protocol

          -  Able to give informed consent

        Exclusion Criteria:

          -  Male gender

          -  Neurological conditions (Examples: Cerebral vascular accident within 6 months prior to
             treatment, Parkinson's disease, Multiple Sclerosis, and Spina Bifida).

          -  Acute urinary tract infection

          -  Treatment with Botox® toxin for other conditions

          -  Allergy to Botox® toxin

          -  Hematuria that has not been worked up

          -  Known bladder malignancy

          -  Previous history of bladder augmentation

          -  Currently pregnant (with no plans to become pregnant within 6 months of enrollment) or
             breastfeeding

          -  Currently taking aminoglycoside antibiotics

          -  Post-void residual (PVR) >150 cc (measured by bladder scan or by catheterization)
             prior to enrollment

          -  History of chronic pain or pain syndromes
A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a TNF-Blocker.
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: rituximab [MabThera/Rituxan]; Methotrexate
Intervention description: 1g iv on days 1 and 15; 10-25mg po/week
Intervention MeSH terms: Rituximab; Methotrexate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will evaluate the efficacy and safety of MabThera in patients with
      active rheumatoid arthritis whose current treatment with one or more TNF blocker had produced
      an inadequate response. Patients will receive MabThera (1g infusion) on day 1 and day 15, and
      will continue on their basic methotrexate therapy (10-25mg/week). The anticipated time on
      study treatment is 3-12 months, and the target sample size is <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  diagnosed RA for >=3 months prior to first administration of study medication;

          -  inadequate response or intolerance to >=1 anti-TNF therapies, alone or in combination
             with methotrexate;

          -  if using NSAIDS, analgesics or oral corticosteroids, must be on a stable dose for >=2
             weeks prior to start of study.

        Exclusion Criteria:

          -  other chronic inflammatory diseases;

          -  use of parental corticosteroids within 4 weeks prior to screening;

          -  severe heart failure, or severe, uncontrolled cardiac disease.
Treatment Response of Injectafer vs Oral Iron to Baseline Hepcidin Levels in Patients With Iron Deficiency Anemia (IDA) Secondary to Inflammatory Bowel Disease (IBD) or Gastric Bypass
Condition: Iron Deficiency Anemia Secondary to IBD or Gastric Bypass
MeSH terms: Neoplasm Metastasis; Inflammatory Bowel Diseases; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Intervention: Injectafer; Ferrous Sulfate tablets
Intervention description: 2 doses of Injectafer, at 15mg/kg for a maximum single dose of 750mg given on days 0 and 7 for a total of up to 1500mg; 325mg (1 tablet) three times a day for 28 days
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 198.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the treatment response of Injectafer vs.
      oral iron to baseline hepcidin levels to determine if any of these select IBD or Gastric
      Bypass patients may demonstrate to be inappropriate for oral iron therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent

          -  Male or female subjects ≥ 18 years of age with clinical diagnosis of IDA secondary to
             IBD or Gastric Bypass

          -  Screening Hemoglobin (Hb) ≤ 11g/dL

          -  Screening Ferritin ≤ 100 ng/mL

          -  Female subjects who are of childbearing age must have a negative pregnancy test at
             screening and be practicing an acceptable method of birth control during the study

        Exclusion Criteria:

          -  Hypersensitivity reaction to any component of IV Injectafer or oral iron

          -  Requires dialysis for treatment of chronic kidney disease (CKD)

          -  During the 30 day period prior to screening has been treated with IV iron

          -  No evidence of iron deficiency

          -  During the 30 day period prior to screening has been treated with a red blood cell
             transfusion.

          -  Any non-viral infection

          -  Known positive hepatitis with evidence of active disease

          -  Received an investigational drug within 30 days of screening

          -  Active malignancy within 5 years. Basal or squamous cell skin cancer is not
             exclusionary

          -  Alcohol or drug abuse within the past 6 months

          -  Hemochromatosis or other iron storage disorders

          -  Pregnant

          -  Any other laboratory abnormality, medical condition, or psychiatric disorders which in
             the opinion of the Investigator would put the subject's disease management at risk or
             may result in the subject being unable to comply with the study requirements
Safety Study of Analgesia After Craniotomy Surgery With End Tidal (ET) Carbon Dioxide (CO2) Monitoring
Condition: Pain
Intervention: Fentanyl; Fentanyl
Intervention description: 25-50 mcg every 20 minutes; 20mcg/demand dose with an 8 minute lock out
Intervention MeSH terms: Fentanyl
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 137.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: pain management; opioid analgesic therapy; safety; craniotomy

Summary:

      This research is being done to compare two methods of giving fentanyl, a narcotic often given
      to patients following brain surgery and determine if one method has more side effects than
      the other. Both of these methods are available in the postoperative treatment of pain. This
      research also is being done to determine if patients receiving narcotic pain medicine will
      benefit from additional monitoring of carbon dioxide levels. Since narcotic pain medicines
      can slow down breathing, The investigators want to see if measuring exhaled carbon dioxide
      levels will help identify a slower breathing rate and improve safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult male and female, English speaking patients undergoing supratentorial craniotomy
             for tumor under general anesthesia at the Johns Hopkins Hospital will be eligible for
             this study.

        Exclusion Criteria:

          -  pregnant women

          -  patients with post operative neurological changes

          -  patients who remain intubated post-operatively

          -  patients who require the use of concomitant administration of sedatives

               -  patients who are unable to initiate a PCA bolus

               -  patients who are unable to communicate verbally

               -  patients who are allergic to fentanyl

          -  patients who have a history of narcotic abuse

          -  patients who have a history of chronic pain requiring opioids

          -  patients who have been in any investigational drug trial within 1 month of the
             treatment day

          -  patients who have chronic respiratory insufficiency
Voriconazole for Secondary Prophylaxis of Invasive Fungal Infections in Patients With Allogeneic Stem Cell Transplants
Condition: Prophylaxis Of Invasive Fungal Infections
MeSH terms: Infections; Communicable Diseases; Mycoses; Invasive Fungal Infections
Intervention: voriconazole
Intervention description: Voriconazole is given to patients at least 48 hours after chemotherapy
Intervention MeSH terms: Voriconazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Invasive Fungal Infection, Allogenic Stem Cell Transplant, prophylaxis, leukemia, voriconazole

Summary:

      To prevent recurrence of invasive fungal infection in patients with allogeneic stem cell
      transplants
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with proven or probable IFI in previous 12 months receiving an allogenic stem
             cell transplant for any haematological disease

        Exclusion Criteria:

          -  Pregnant or lactating women

          -  Severe disease other tham the underlying condition

          -  Active, symptomatic uncontrolled Invasive Fungal Infection

          -  Any evidence of active fungal disease as defined by MSG-EORTC criteria

          -  Concomitant use of Voriconazole 36 hours before chemotherapy until 48 hours after
             chemotherapy

          -  Other medical conditions, including HIV positive serology that would interfere with
             the evaluation of therapeutic response or safety of study drug
Antibiotic Resistance and Microbiome in Children Aged 6-59 Months in Nouna, Burkina Faso
Condition: Child Development
Intervention: Azithromycin; Amoxicillin; Cotrimoxazole; Placebo
Intervention description: Children in this arm will receive Azithromycin once a day.; Children in this arm will receive Amoxicillin twice a day.; Children in this arm will receive co-trimoxazole once a day.; Children in this arm will receive Placebo once a day.
Intervention MeSH terms: Amoxicillin; Azithromycin; Trimethoprim, Sulfamethoxazole Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Households will be randomized to one of four treatment arms (azithromycin, cotrimoxazole, amoxicillin, or placebo), and each child age 6-59 months in the household will receive 5 days of treatment. One child within each of the antibiotic households will be randomly selected to receive placebo instead of the antibiotc, to allow for study of indirect effects of antibiotic use
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: double blind
Enrollment: 252.0
Sex: All
Minimum age: 6 Months
Maximum age: 59 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: infection; azithromycin; amoxicillin; co-trimoxazole; trachoma; mass treatment

Summary:

      The use of antibiotics has saved millions of human lives, however consumption of antibiotics
      can select for antibiotic resistant organisms and may lead to changes in commensal
      microbiome. This study is designed to estimate the effect of antibiotic consumption on
      microbiome in a rural region of rural Burkina Faso. Changes in the intestinal and
      nasopharyngeal microbiome and resistome following a short course of antibiotics will be
      measured.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Households will be eligible for inclusion in the study if they have 2 or more children
             aged 6 months to 59 months currently residing in the household. Children from the
             household will be eligible if they are 6-59 months of age and are not currently
             receiving antibiotic treatment

        Exclusion Criteria:

          -  Children who are allergic to any of the study antibiotics will be excluded.
             Individuals aged under 6 months and 5 years or older will be excluded. Children
             already receiving antibiotics for an ongoing disease will be excluded.
A Clinical Trial Comparing the Efficacy and Safety of Exubera® and Lantus®
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin Glargine (Lantus®); Inhaled Human Insulin (Exubera®)
Intervention description: Patient will be randomized to Lantus® while remaining on pre-study oral hypoglycemic agents.; Patient will be randomized inhaled insulin while remaining on pre-study oral hypoglycemic agents.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 261.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: type 2 diabetes, insulin, glycemic control

Summary:

      To compare efficacy and safety of Exubera® vs Lantus® in patients with type 2 diabetes
      mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diabetes Mellitus, Type 2 on oral agents

          -  Age > 30 years

        Exclusion Criteria:

          -  Severe Asthma, severe Chronic Obstructive Pulmonary Disease

          -  Smoking
A Safety and Efficacy Study of BOTOX® in Korean Adults With Chronic Migraine
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Intervention: botulinum toxin Type A
Intervention description: Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 280.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of BOTOX® treatment in Korean adults with
      chronic migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ethnically Korean with a diagnosis of chronic migraine

        Exclusion Criteria:

          -  Anticipated need for botulinum toxin treatment for any reason other than chronic
             migraine during the study

          -  Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral
             sclerosis