bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Neonatal Abstinence Syndrome
Condition: Neonatal Abstinence Syndrome
MeSH terms: Neonatal Abstinence Syndrome; Syndrome
Intervention: Methadone; Diluted Deodorized Tincture of Opium
Intervention description: Concentration is 1mg/mL administered every 12 hours given on sliding scale in response to last NAS score.; Concentration is 1:24 dilution for a concentration of 0.4%
Intervention MeSH terms: Methadone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 1 Day
Maximum age: 6 Days
Healthy volunteers: No
Keywords: Neonatal Abstinence Syndrome; Methadone; Diluted Deodorized Tincture of Opium; dDTO; Phenobarbital

Summary:

      This study compares treatment of Neonatal Abstinence Syndrome (NAS) with two different drugs
      for the difference in the length of treatment. This is a randomized, open-label comparison of
      phenobarbital and methadone versus phenobarbital and diluted deodorized tincture of opium
      (dDTO) where phenobarbital is the initial drug used to stabilize neonatal withdrawal.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Evidence of opioid withdrawal clinically as defined by 2 NAS scores >8 or 1 NAS score
             >12 over a 4 to 8 hour time period, AND

          -  Gestation >=35 weeks at entry defined by best obstetrical and physical exam criteria,
             AND

          -  Medically stable condition, other than in opioid withdrawal, in the opinion of the
             attending neonatologist, AND EITHER,

          -  Meconium or urine drug screen positive for opioids on mother or newborn, OR

          -  Known maternal prescription of opioids for chronic pain management during at least the
             last trimester of pregnancy, OR

          -  Known maternal prescription of opioids for treatment of addiction, OR

          -  Suspected or admitted abuse with opioid drugs

          -  Infants of mothers with a medical or psychiatric diagnosis will not be excluded,
             unless the maternal diagnosis precludes informed consent

        Exclusion Criteria:

          -  Gestation <35 weeks at entry defined by best obstetrical and physical exam criteria.

          -  Hypoglycemia, hypomagnesaemia, or hypocalcaemia until corrected.

          -  Serious medical illness such as sepsis, pneumonia, hyperthyroidism, meningitis,
             intracranial hemorrhage, perinatal depression, or respiratory failure requiring
             admission to the NICU.

          -  Evidence of major congenital anomalies or genetic syndromes that impact the neonatal
             course.
Treatment of Myofascial Pain Syndrome With Lidocaine Injection and Physical Therapy.
Condition: Myofascial Pain Syndrome; Pain; Myofascial Trigger Point Pain; Musculoskeletal Pain
MeSH terms: Musculoskeletal Pain; Myofascial Pain Syndromes; Fibromyalgia; Syndrome; Somatoform Disorders
Intervention: Physical therapy; Lidocaine injection; Lidocaine injection + physical therapy
Intervention description: Twelve sessions (3 per week); blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose.; blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 127.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Myofascial pain; Trigger points.; Lidocaine injection.; Physical therapy

Summary:

      Background: Myofascial pain syndrome (MPS) of the shoulder girdle and cervical region is a
      common musculoskeletal problem that is often chronic or recurrent. It has demonstrated the
      effectiveness of different treatments such as exercise, injection but not comparing them with
      each other. The objective of this research was to demonstrate whether lidocaine injection
      into trigger points combined with a physical therapy program was more effective than each
      separatetreatment in improving pain, function and quality of life in a group of patients with
      myofascial pain syndrome (MPS) of the shoulder girdle and cervical region.

      Design: Single-blind, randomized, controlled clinical trial with three parallel groups in the
      departments of physical medicine and rehabilitation of two urban hospitals. There were 127
      patients with myofascial pain in the shoulder girdle for more than six weeks in length and
      pain greater than 40 mm on the visual analog scale (VAS). There were three intervention
      groups: physical therapy (PT), lidocaine injection (LI), or the combination of both (PT +
      LI). The primary outcome at one month was the VAS, and the secondary outcomes were measured
      using the SF36 pain scaleat one and three months.

      Keywords: Myofascial pain, trigger points, lidocaine injection, physical therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cervical Pain at least six weeks

          -  At least 40 mm in the VAS

          -  They cannot been received treatment like physical therapy or analgesics

          -  Maximum score of PHQ 16 points

        Exclusion Criteria:

          -  Depression

          -  Fibromyalgia

          -  Cervical Radiculopathy
Ketamine and Propofol Combination Versus Propofol for Upper Gastrointestinal Endoscopy
Condition: Obesity; Bariatrics; Sleep Apnea Syndromes; Gastric Bypass; Endoscopy
MeSH terms: Sleep Apnea Syndromes
Intervention: Ketofol; Propofol; Saline
Intervention description: 50mg of Ketamine mixed with 100mg of Propofol; 100mg of Propofol; 1mL of saline
Intervention MeSH terms: Ketamine; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Ketamine; Propofol; Ketofol; Obese; Upper gastrointestinal endoscopy; Sedation; Bariatric

Summary:

      Propofol is one of the most popular anesthetic drugs used for sedation during upper
      gastrointestinal endoscopies due to its quick onset and quick resolution of symptoms allowing
      patients to leave the hospital sooner. However, when administered it can also slow the
      breathing of patients and cause others to have upper airway obstruction (such as snoring)
      which can impede proper spontaneous breathing. Ketamine is an agent that is capable of
      providing both pain control and sedation while having either minimal effect on breathing or
      promoting spontaneous breathing. Combining Ketamine with Propofol has the potential to reduce
      the total amount of Propofol used resulting in a procedure being performed under the same
      level of sedation but without the downside of reduced spontaneous breathing. Patients who are
      obese (defined as body mass index greater than 35) tend to be even more susceptible to this
      effect of Propofol. The researchers are investigating whether the addition of Ketamine will
      indeed allow for this continued comfortable level of sedation while promoting continued
      spontaneous breathing in obese patients undergoing upper gastrointestinal endoscopies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI > 30

          -  Undergoing an upper gastrointestinal endoscopy

        Exclusion Criteria:

          -  History of schizophrenia/schizoaffective disorder

          -  History of bipolar disorder

          -  History of dementia

          -  Non-English Speaking

          -  History of Glaucoma

          -  Craniofacial Abnormalities

          -  Epilepsy

          -  Allergy to Propofol

          -  Allergy to Ketamine

          -  Current known intracranial mass/lesion
Multihance at 3 Tesla (3T) in Brain Tumors
Condition: Brain Tumor
MeSH terms: Brain Neoplasms
Intervention: Multihance; Arm 2 - Magnevist
Intervention description: 0.5 M at a single injection; 0.5 M Magnevist at a single dose injection
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Compare the efficacy of MultiHance and Magnevist
    

Eligibility criteria:

        Inclusion Criteria:

          -  Was 18 years or older

          -  Provided written informed consent

          -  Scheduled for MRI

          -  Confirmed or highly suspected to have brain tumor(s) and willing to undergo two MRI
             exams within 14 days

        Exclusion Criteria:

          -  Pregnant or lactating females

          -  Allergy to one or more of the ingredients in the products or hypersensitivity to any
             metals

          -  Congestive heart failure, class IV

          -  Previous stroke in the past year

          -  Received another contrast agent within 24 hours pre and post each exam

          -  Investigational product

          -  Contraindications to MRI

          -  Severe claustrophobia

          -  Surgery with 3 weeks prior

          -  Steroid therapy or radiosurgery between two exams
Postmarketing Clinical Study on AO-128
Condition: Impaired Glucose Tolerance (IGT)
MeSH terms: Glucose Intolerance
Intervention: AO-128
Intervention description: AO-128 tablet
Intervention MeSH terms: Voglibose
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 197.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of open-label study is to evaluate the efficacy and safety of AO-128 (Voglibose)
      0.6 mg/day in patients with impaired glucose tolerance (IGT) who had been non-responsive to
      diet therapy and exercise therapy, and follow up the progress after the end of treatment in
      patients who was assessed as normoglycemic.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients on diet therapy and exercise therapy for 3 to 6 months prior to the start of
             screening, with baseline (fasting ) plasma glucose < 126 mg/dL and 2-hour plasma
             glucose of 140 to 199 mg/dL (revised WHO criteria) during a 75 g oral glucose
             tolerance test (OGTT) in the screening period

          2. Patients meeting any of 1 through 4 below:

               -  1) Comorbid hypertension or high normal blood pressure

               -  2) Comorbid dyslipidemia

               -  3) Comorbid obesity

               -  4) Patients with up to a second-degree family history of type 2 diabetes mellitus

          3. Patients with HbA1c < 6.5% in the screening period

          4. Male or female patients at least 20 years of age at the time informed consent was
             obtained

          5. Treatment category: Outpatient

        Exclusion Criteria:

          1. Patients previously diagnosed with diabetes mellitus.

          2. Patients with apparent impaired glucose metabolism or with a disease or condition
             potentially involving impaired glucose metabolism.

          3. Patients with serious hepatic impairment.

          4. Patients with serious renal impairment.

          5. Patients with serious cardiac, cerebrovascular, pancreatic, hematologic, or other
             disease.

          6. Patients with a history of intestinal obstruction or a history of laparotomy within 6
             months (24 weeks) before the start of screening.
Efficacy of Seven-day Combined Rabeprazole Plus Levofloxacin Plus Augmentin for Eradication of Helicobacter Pylori
Condition: Helicobacter Pylori Infection
Intervention: Levofloxacin-Amox/clav.; Clarithromycin-Amoxicillin
Intervention description: Levofloxacin, 500 mg b.i.d., amoxicillin/clavulanate, 875mg/125mg b.i.d. and rabeprazole, 20 mg b.i.d. for 7 days.; Clarithromycin, 500 mg b.i.d., amoxicillin, 1000 mg b.i.d. and rabeprazole 20 mg b.i.d. for 7 days.
Intervention MeSH terms: Amoxicillin; Clarithromycin; Levofloxacin; Ofloxacin; Clavulanic Acid; Amoxicillin-Potassium Clavulanate Combination; Rabeprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 208.0
Sex: All
Minimum age: 20 Years
Maximum age: 95 Years
Healthy volunteers: No
Keywords: Helicobacter pylori; Levofloxacin; Amoxicillin/clavulanate; Rabeprazole; Eastern Taiwan

Summary:

      This prospective controlled randomized open-label clinical trial is designed to determine the
      eradication rate of 7-day levofloxacin, amoxicillin/clavulanate and rabeprazole regimen
      compared with 7-day standard triple therapy for adults infected with Helicobacter pylori in
      Eastern Taiwan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient proved with infection of H. pylori in gastric mucosa

          -  Patient with signed informed consent.

        Exclusion Criteria:

          -  woman in breast feeding or pregnancy.

          -  allergy or severe adverse effects to drugs used in study.

          -  severe complications of peptic ulcer disease (like perforation or obstruction).

          -  patients with history of cancer or failure of major organs.
Evaluating the Efficacy and Safety of Extended Release Hydromorphone (Exalgo) in Patients With Neuropathic Pain
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Intervention: Hydromorphone
Intervention description: Oral hydromorphone extended release, once daily
Intervention MeSH terms: Hydromorphone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Pain; Neuropathy; Neuropathic Pain; Hydromorphone

Summary:

      The purpose of this study is to find out if Exalgo (r) is beneficial for the patients with
      neuropathic pain.
    

Eligibility criteria:

        Inclusion Criteria:

          1. individuals with chronic pain of more than 6 months duration

          2. pain is determined to be secondary to a documented neuropathy

          3. patients who are tolerant of opiates (60 mg of morphine or equivalent for at least one
             week)

          4. male or female patients aged 18-75 yrs and have signed a written informed consent form
             and privacy statement

          5. female patients of child-bearing potential must be using an acceptable form of birth
             control

        Exclusion Criteria:

          1. pregnant or lactating women

          2. allergy to morphine or its derivatives

          3. history of alcohol or substance abuse in the last 3 yrs

          4. participation in any other clinical trial in the last 30 days

          5. uncontrolled pain

          6. patient who is deemed to be medically unstable by principal investigator

          7. history of severe lung disease or asthma that is deemed medically significant by
             principal investigator
Long Term Effectiveness of Trigger Finger Injections With Triamcinolone vs. Dexamethasone
Condition: Trigger Finger Disorder
MeSH terms: Trigger Finger Disorder
Intervention: Triamcinolone; Dexamethasone
Intervention description: Triamcinolone acetonide (Kenalog; 10 mg/mL; insoluble). This will be mixed with 1% lidocaine without epinephrine; dexamethasone sodium phosphate (Decadron; 4 mg/mL; soluble). Again, this will be mixed with 1% lidocaine without epinephrine
Intervention MeSH terms: Dexamethasone; Triamcinolone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: trigger finger

Summary:

      Trigger finger (stenosing tenosynovitis) is a very common condition and in office treatment
      with corticosteroid injection is widely accepted to be first line treatment. Previous studies
      have reported resolution of triggering after injection at rates ranging from 50% to 93%. Many
      factors contribute to this variability, including duration of symptoms, presence of diabetes,
      etc. This study will be a single center, prospective, randomized control trial. Patients will
      be collected into two different cohorts. The main cohort will be of patients with primary,
      idiopathic trigger finger. A second cohort of patients with diabetes will also be collected
      for secondary study questions. Study procedures will include clinical examination of the
      patient, injection of trigger fingers with mix of local anesthetic and one of two steroids,
      possible repeat trigger finger injections, and if patients are so indicated, surgical
      treatment of the trigger finger. Surgical treatment is considered clinical care of these
      patients who have continued or recurrent symptoms and the surgical treatment would not be
      considered part of this study. During the study, patients will also fill out surveys about
      their symptoms. The study drugs used will be 1% lidocaine without epinephrine mixed with
      either triamcinolone or dexamethasone. These medications are FDA approved for injection
      treatment of "acute non-specific tenosynovitis." This indication includes trigger finger
      which is also known as acute stenosing tenosynovitis. The package inserts listing the
      indications for use of these medications are included in the attachments portion of the IRB
      application.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Newly diagnosed primary, idiopathic trigger finger(s)

          -  Quinnell grade II or greater.

          -  Patients must be 18 years of age or older

        Exclusion Criteria:

          -  patients taking any diabetic medications.

          -  any history of inflammatory or autoimmune arthritis

          -  history of prior trauma to the tendon of the affected digit

          -  pregnancy, and breast feeding
Colposeptine for the Treatment of Bacterial Vaginosis
Condition: Vaginosis, Bacterial
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Intervention: Colposeptine; Metronidazole
Intervention description: Colposeptine will be administered transvaginally at a dose of 1 capsule every day for 12 consecutive days; Metronidazole will be administered orally at a dose of 400 mg twice a day for 7 days
Intervention MeSH terms: Metronidazole; Chlorquinaldol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 133.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Vaginosis, Bacterial; Colposeptine; Metronidazole

Summary:

      This is a prospective, randomized, controlled and multi-center trial to assess the use of
      colposeptine in female subjects with bacterial vaginosis. A total of 480 subjects were
      planned to be enrolled in various centers in China.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female subjects in reproductive age and older than 18 year

          -  Subjects with normal sexual activity

          -  Subjects with symptoms such as vulva-vaginal irritation or abnormal vaginal discharge

          -  Subjects with Nugent Score greater than or equal to 7

          -  Subjects who are willing to use contraception

          -  Subjects who are willing to refrain from the use of other vaginal products throughout
             the study

          -  Subjects who sign informed consent form and agree to follow-up on time

        Exclusion Criteria:

          -  Subjects without sexual activity

          -  Pregnant or lactating female subjects

          -  Subjects with a history of recurrent bacterial vaginosis

          -  Subjects diagnosed with trichomonas vaginitis，vulvovaginal candidiasis，chlamydia or
             gonococcus infection.

          -  Subjects who are unwilling to refrain from the ingestion of any alcoholic beverages
             during the 7 day course of oral metronidazole therapy

          -  Subjects who are under treatment by lithium, phenobarbitone, coumadine anticoagulant,
             cyclosporine or disulfiram by the time of inclusion (interactions with other products
             and metronidazole)

          -  Subjects who are undergoing systemic or topical treatment with antibiotics, steroids,
             immunosuppressive, cytostatic or antimetabolic agents by the time of inclusion

          -  Female subjects with a history of peripheral neuropathy

          -  Female subjects who have participated in another clinical trial or have taken an
             experimental drug within the past 30 days

          -  Subjects who are unable to give written informed consent
Benzocaine Versus Placebo Spray for Pain Relief at Hysterosalpingogram
Condition: Pain Relief; Analgesia
Intervention: Benzocaine; Saline spray
Intervention description: A saline spray will be used in the placebo group
Intervention MeSH terms: Benzocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hysterosalpingogram; HSG; Pain relief; Analgesia; Benzocaine

Summary:

      The objective of this study is to assess the utility of benzocaine spray versus a placebo
      spray in alleviating pain during and after hysterosalpingogram (HSG).
    

Eligibility criteria:

        Inclusion Criteria:

          -  All women who present to Penn Fertility Care over the age of 18 years old

        Exclusion Criteria:

          -  Patients under the age of 18

          -  Pregnant patients

          -  Patients with a history of hypersensitivity to benzocaine

          -  Patients with a history of asthma or bronchitis