bioihbjkbjnl/mcl2 huggingface dataset:
Pressure Ulcer Healing With Microcyn
Condition: Pressure Ulcer; Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Pressure Ulcer; Ulcer
Intervention: Microcyn; Sterile saline
Intervention description: Microcyn is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with Microcyn twice daily for the earlier of total wound closure or Week 24; Sterile saline is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with sterile saline twice daily for the earlier of total wound closure or Week 24
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Spinal cord injuries; Pressure ulcer

Summary:

      The purpose of this study is to test how well Microcyn™ works on Stage 3 and Stage 4 pressure
      ulcers compared to sterile saline among persons with spinal cord injury.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 17 years

          -  Persons with spinal cord injury

          -  Having Stage III/IV pressure ulcer(s)

          -  Able to fulfill all obligations of the study

        Exclusion Criteria:

          -  Pressure ulcers scheduled for surgical closure within 14 days

          -  Use of any immunosuppressant medications within 30 days of screening

          -  Having conditions that put the subject at significant risk

          -  Medically unstable or has a life expectancy of less than 12 months

          -  Current enrollment in an investigational drug or device study or participation in such
             a study within the last 30 days

          -  Pregnant women
Effects of Garlic Supplements on Opioids in Healthy Volunteers
Condition: Healthy, No Evidence of Disease
Intervention: garlic powder tablets; oxycodone
Intervention description: Each Garlicin tablet has a claimed allicin content of 3,200 microgram per tablet; Single administration of three 5-mg oxycodone tablets or a 15-mg dose
Intervention MeSH terms: Oxycodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 15.0
Sex: All
Minimum age: 21 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy, No Evidence of Disease

Summary:

      RATIONALE: Garlic supplements may alter the pharmacokinetics of oxycodone, thereby affecting
      its effectiveness as an opioid analgesic for the relief of moderate or severe pain.

      PURPOSE: This randomized phase 4 trial is studying how garlic supplements may change the
      pharmacokinetics of oxycodone and its analgesic and side effects in healthy volunteers.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  Healthy volunteer

          -  Body mass index 20-32

        EXCLUSION CRITERIA:

          -  Not pregnant

          -  No history of cardiopulmonary, liver, renal, endocrine, neurologic, or psychiatric
             disease

          -  No anemia

          -  No known adverse reactions to opioids, benzodiazepines, cardiac glycosides, or garlic
             supplements

          -  No known allergy or hypersensitivity to sulfur-containing food or drugs

          -  No significant gastrointestinal intolerance to lactose in dairy products

          -  No recent history of alcohol or substance abuse

          -  No history of or concurrent heavy daily consumption of allium vegetables (i.e.,
             garlic, shallots, leeks, and chives)

          -  No handicaps due to visual and hearing impairments

          -  No resting heart rate < 50 beats per minutes

          -  No abnormal cardiac rhythm by EKG

          -  No unusually sensitive response or resistance to pain stimulation (Cold Pressor Test)

          -  Must be right handed

          -  No color blindness

          -  No history of learning disabilities or dyslexia

          -  Must be literate and proficient in English

          -  Must be a nonsmoker

          -  No concurrent medication except oral contraceptives

          -  No concurrent grapefruit or grapefruit juice

          -  No other concurrent over-the-counter herbal products or herbal tea
Efficacy of Preoperative Autologous Blood Donation and Tranexamic Acid in Revision Total Hip Arthroplasty
Condition: Revision Total Hip Arthroplasty (RTHA)
Intervention: transfused pre-operatively donated autologous blood.; intravenous tranexamic acid (TXA) infusion; transfused only allogeneic blood.
Intervention description: Pre-operative autologous donation for minimising perioperative allogeneic blood transfusion; Intravenous tranexamic acid is a safe pharmacological treatment to reduce blood loss and transfusion requirements in patients undergoing major orthopedic surgery.
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 60.0
Sex: All
Minimum age: 60 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Autologous blood donation, allogeneic blood transfusion

Summary:

      Sixty patients aged between 60 and 75 years old of both sex of ASA physical status I and II
      were included in this randomized study who were divided into the study group of 30 patients
      who had been transfused autologous blood and the control group of 30 patients who had been
      transfused only allogeneic blood. Parenteral iron preparation was given to all patients of
      the study group after each donation. Intraoperatively all patients of the study group
      received 2 grams of intravenous tranexamic acid. This study was conducted through the
      laboratory analysis of the hemoglobin and the hematocrit values during blood donation and for
      both groups in the pre-operative and the post-operative period and the assessment of the
      amount of transfused blood units in both groups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Elective revision total hip replacement surgery was performed in 60 patients aged
             between 60 and 75 years old of both sex of ASA physical status I and II of 70-90 kg
             body weight and height 160-180 cm.

        Exclusion Criteria:

          -  This study excluded cases of revision total hip arthroplasty (RTHA) for infection or
             fractures as well as early revisions for dislocations secondary to implant
             malposition. Preoperative autologous blood donation was not done in patients with
             cardiac decompensation, severe hemodynamic problems, respiratory insufficiency, severe
             defect of central nervous system, active infection, blood disease or coagulopathies.
A Comparison of Two Therapeutic Strategies for the Treatment of Aspirin-associated Peptic Ulcers
Condition: Peptic Ulcer
MeSH terms: Peptic Ulcer; Ulcer
Intervention: aspirin
Intervention description: aspirin, 100 mg, qd x 8 weeks
Intervention MeSH terms: Aspirin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 178.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: aspirin; peptic ulcer

Summary:

      Esomeprazole plus aspirin compared with esomeprazole alone for the treatment of
      aspirin-related peptic ulcers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  aspirin users who have a peptic ulcer confirmed by endoscopy

        Exclusion Criteria:

          -  serious medical illness (including cardiovascular events within 6 months before
             endoscopy)

          -  acute gastrointestinal bleeding

          -  a history of gastric or duodenal surgery

          -  allergic to the study drugs

          -  require long-term treatment with non-aspirin nonsteroidal anti-inflammatory drugs
             (NSAIDs), antiplatelet agents, or anticoagulant agents

          -  pregnancy
Evaluation of Succinate Metoprolol on Heart Rate in the Stable Angina Patients
Condition: Angina Pectoris
MeSH terms: Angina Pectoris; Angina, Stable
Intervention: Succinate Metoprolol (Betaloc ZOK®); Succinate Metoprolol (Betaloc ZOK®)
Intervention description: treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks; Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
Intervention MeSH terms: Metoprolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 251.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: angina pectoris; chest pain; heart rate

Summary:

      The purpose of this study is to evaluate the effects of Succinate Metoprolol(Betaloc ZOK®)
      (95 - 190 mg) on heart rate in the Stable angina patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of informed consent prior to any study specific procedures

          -  Chinese patients

          -  Heart rate ≥ 65bpm

          -  Has been diagnosed as Stable angina for at least 1 month and with stable angina
             pectoris symptoms within 2 weeks previous to enrolment(Please find the diagnose
             criteria of Stable angina on Appendix C)

          -  With Left ventricular ejection fraction ≥ 50% according to ultrasound cardiogram;

          -  Has been on beta-blockers for at least 4 weeks*, on the dose equivalent to Betaloc
             ZOK® 23.75-47.5mg/day.

        Exclusion Criteria:

          -  Acute myocardial infarction within 6 months

          -  Unstable angina or Prinzmetal's angina

          -  II degree of AV block or greater

          -  Significant clinical, laboratory or electrocardiographic abnormalities that would
             place the subject at undue risk (in the Investigator's opinion) including:

          -  Significant renal impairment (serum creatinine > 2.0 mg/dL)

          -  Serum Alanine Aminotransferase or Aspartate Aminotransferase > 3 x upper limit of
             reference range

          -  Serum potassium < 3.0 mEq/L

          -  Serum sodium ≤ 130 mEq/L

          -  Acute or chronic hepatitis or cirrhosis (clinical diagnosis)

          -  Uncontrolled hyperthyroidism (clinical diagnosis)

          -  Systolic blood pressure ≥ 180 mmHg, or < 100mmHg at enrolment

          -  Patients with unstable, not compensated heart failure (pulmonary oedema, hypoperfusion
             or hypotension)
An Efficacy and Safety Study of Osmotic Release Oral System (OROS) Methylphenidate in Participants With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Osmotic Release Oral System (OROS) Methylphenidate Hydrochloride
Intervention description: OROS methylphenidate hydrochloride (HCL) will be given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose will be increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
Intervention MeSH terms: Methylphenidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 142.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Attention Deficit Hyperactivity Disorder; Methylphenidate Hydrochloride

Summary:

      The purpose of this study is to evaluate the safety and efficacy of Osmotic Release Oral
      System (OROS) methylphenidate in participants with Attention Deficit Hyperactivity Disorder
      (ADHD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants voluntarily provided informed consent to participate in the study

          -  Participants with written informed consent to participate in the study voluntarily by
             caregivers/legal representatives

          -  Participants who were capable to follow the study visit schedule well and their
             parents/caregivers who were willing to complete the assessments specified in the
             protocol and were capable to complete them

          -  Participant and his/her parent/guardian able to understand the study participation and
             to request withdrawal from the study voluntarily at any time

          -  Participants who were satisfied in diagnosis of Diagnostic and Statistical Manual of
             Mental Disorders Fourth Edition (DSM-IV) Attention Deficit Hyperactivity Disorder
             (ADHD) and determined to require drug therapy

        Exclusion Criteria:

          -  Participants who have known hypersensitivity (altered reactivity to an antigen, which
             can result in pathologic reactions upon subsequent exposure to that particular
             antigen) to methylphenidate HCL

          -  Participants who have significant suicidal ideation

          -  Participants with mental retardation

          -  Participants who meet DSM-IV diagnostic criteria for current major depressive disorder
             or anxiety disorder requiring drug therapy

          -  Participants who have abnormalities in the Electrocardiography (ECG) or show
             clinically significant abnormalities of laboratory results, including serum
             chemistries and hematology
Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis
Condition: Active Rheumatoid Arthritis; Arthritis, Rheumatoid; Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: etanercept
Intervention MeSH terms: Etanercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 306.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Study to evaluate whether there is sustained remission and productivity in subjects with
      early rheumatoid arthritis started on etanercept plus methotrexate treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of early rheumatoid arthritis.

          -  Methotrexate (MTX) naive.

          -  Active early rheumatoid arthritis at the time of enrollment.

        Exclusion Criteria:

          -  Previous or current treatment with etanercept, other tumor necrosis factor-alpha (TNF)
             inhibitors, or other biologic agents.

          -  Concurrent treatment with any disease-modifying anti-rheumatoid drugs (DMARD), within
             4 weeks before baseline.

          -  Concurrent treatment with more than 1 non-steroidal anti-inflammatory drug (NSAID) at
             baseline.
Heart Rate Regularization in Patients With Permanent Atrial Fibrillation Post Marketing Study
Condition: Permanent Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Vitatron pacemaker C20 SSIR or T20 SSIR models
Intervention description: VRS: special function that automatically adapts pacing rate to regularize cardiac cycles
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Permanent atrial fibrillation; VVI(R) pacing; rate regularization

Summary:

      The purpose of this study is to monitor heart rate regularization in patients with permanent
      atrial fibrillation and standard indication for single chamber rate adaptive pacing VVI(R).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has signed informed consent form

          -  Patient with permanent atrial fibrillation, standard indication for VVI(R) pacing, and
             at least 1 episode of rate irregularity in the last month

          -  New York Heart Association (NYHA) Class I, II, III

          -  Patient is able to comply with follow-up times and will comply with the protocol

          -  > 18 years of age

        Exclusion Criteria:

          -  Paroxysmal atrial fibrillation

          -  NYHA Class IV

          -  Left ventricular ejection fraction (LVEF) < 35

          -  Patients with unstable angina

          -  Patients who have experienced an acute myocardial infarction or received coronary
             artery revascularization (CABG), or coronary angioplasty (PTCA) within 3 months prior
             to enrolment

          -  Patient candidate for cardiac surgery, or coronary angioplasty (PTCA)

          -  Patients who experienced a cardiovascular accident (CVA) or transient ischemic attack
             (TIA) with permanent disability

          -  Life expectancy < 12 months due to other medical conditions

          -  Pregnancy

          -  The patient is enrolled in any concurrent (drug and/or device) study
Comparison of Two Techniques of IV Lidocaine on Propofol Injection Pain
Condition: Injections, Intravenous
Intervention: Lidocaine injection flushed; Lidocaine injection tourniquet
Intervention description: The investigator administers IV lidocaine and flushes it into the subject prior to administering propofol.; Intravenous lidocaine: tourniquet
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, controlled trial of two methods of administering lidocaine prior to propofol injection
Masking: Single (Participant)
Masking description: The participant is not told which group they are randomized to. However, a tourniquet is applied in the experimental group, thus some subjects may reason that they are in the experimental group. The study coordinator is aware which group the subject is in.
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Propofol; lidocaine; pain

Summary:

      Intravenous lidocaine is commonly given through an intravenous (IV) line prior to injection
      of propofol to reduce the amount of pain during propofol injection. The investigators want to
      study if giving the lidocaine through the IV while the forearm on the same limb has a
      tourniquet applied to it to prevent "washing out" of the lidocaine prior to propofol
      injection helps reduce propofol injection pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any subject at North Carolina Baptist Hospital scheduled for a procedure in which they
             will receive propofol for sedation or anesthesia and will not be receiving any other
             medications prior to the propofol injection.

          -  Cases must be schedule to have a duration less than 60 minutes.

        Exclusion Criteria:

          -  Subjects are excluded if they cannot verbalize a rating of pain

          -  Subjects are excluded if they require intravenous medications prior to the study
             period
Methadone and Medication Abortion
Condition: Pain; Medical Abortion
Intervention: Methadone Pill; Ibuprofen
Intervention description: All participants will be given a 5mg methadone tablet to be taken immediately following the misoprostol dose.; All participants will be provided additional analgesics (ibuprofen 800mg x4 tabs) available for use as needed every eight hours.
Intervention MeSH terms: Ibuprofen; Methadone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Oral methadone; Pain control

Summary:

      Pain has been recognized to be the most common and predictable side effect of medication
      abortion, causing significant distress associated with the process. Yet there is little known
      about the appropriate management of pain during this process, with no current evidence based
      recommendations for optimal analgesic regimens during the first trimester.

      The goal of this study is to evaluate the efficacy of oral methadone for pain control during
      medication abortion. The current medication regimen used to perform medication abortion is a
      dose of mifepristone (antiprogesterone) orally, followed by a dose of misoprostol
      (prostaglandin analogue) 24 to 72 hours later. Patients are prescribed a standard dose of
      ibuprofen 600-800mg tabs for pain control during the process. The investigators will conduct
      a non-randomized, pilot study with 25 patients evaluated at the Boston Medical Center family
      planning clinic at 10 weeks of gestation or less for medication abortion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women requesting medication abortion up to 10 weeks gestation

          -  Fluent English speaking

          -  Able and willing to receive and send text messages and receive phone calls

          -  Opioid naive

          -  Healthy patients with no significant comorbidities

        Exclusion Criteria:

          -  Any history of drug or alcohol use, opioid use in last 30 days, chronic use of pain
             medications, or use of benzodiazepines.

          -  Any chronic disease including renal, liver, respiratory or cardiac disease

          -  Any known allergies to mifepristone, misoprostol, nonsteroidal anti-inflammatory drugs
             (such as ibuprofen) and methadone.

          -  Known history of QT prolongation