bioihbjkbjnl/mcl2 huggingface dataset:
Chronic Pain Risk Associated With Menstrual Period Pain
Condition: Cystitis, Interstitial; Dysmenorrhea; Migraine Disorders; Pelvic Pain; Endometriosis; Visceral Pain; Chronic Pain
MeSH terms: Migraine Disorders; Endometriosis; Cystitis; Cystitis, Interstitial; Chronic Pain; Pelvic Pain; Dysmenorrhea; Visceral Pain
Intervention: cyclic microgestin 1/20; continuous microgestin 1/20
Intervention description: Cyclic OC Use - Participants will ingest pills containing active hormones for 21 days followed by 7 days of no pills, and then the cycle will repeat; Continuous OC use - Pills containing hormones will be taken every day for 1 year
Intervention MeSH terms: Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination; Norinyl; Mestranol; Norethindrone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 353.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cystitis, Interstitial; Dysmenorrhea; Migraine Disorders; Cross Organ Sensitization; Pelvic Pain; Endometriosis; Contraceptives, Oral; Birth Control Pills; Painful Bladder Syndrome; Visceral Pain; Chronic Pain

Summary:

      The purpose of this study is to determine if some women with dysmenorrhea (painful periods)
      are at higher future risk of developing chronic pelvic pain (CPP) and if oral contraceptives
      (OC) can be used to reverse this chronic pain risk.

      Investigators will examine whether dysmenorrhea produces CPP via repetitive cross organ
      sensitization (COS) episodes. The use of cyclical OCs to eliminate dysmenorrhea is expected
      to reduce COS and decrease the risk of developing CPP.
    

Eligibility criteria:

        Inclusion Criteria:

        All

          -  Reproductive age women (18-45)

        For dysmenorrhea and D+COS group only:

          -  Participants must have had regular (22-45 day) menstrual cycles over at least a two
             month period preceding testing

        Exclusion Criteria:

        All

          -  presence of active pelvic or abdominal malignancies (primary or metastatic)

          -  active genitourinary infection in the last four weeks

          -  unable to read or comprehend the informed consent in English

          -  unwilling to undergo pelvic examination/testing

          -  presence of hypertension or risk for developing hypertension, and

        For dysmenorrhea and D+COS group only:

          -  absence of regular menses (including current pregnancy, recent pregnancy, or active
             breast feeding) unwilling to take either cyclic or combined OCs

          -  unwilling to withdraw from OCs for two months prior to the sensory testing study
             visit.
ATAREAL (Antihistamine Treatment for Allergic Rhinitis in Real Life)
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: Levocetirizine
Intervention description: Pharmaceutical form: Tablet
Concentration: 5 mg
Route of administration: Oral use
Intervention MeSH terms: Levocetirizine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Persistent Allergic Rhinitis; HDM; Parietaria; sneezing; rhinorrhea; ocular pruritus; Rhinasthma; inflammatory cells; ICAM-1; ATAREAL; Xyzal; Levocetirizine

Summary:

      Comparison of clinical efficacy and safety of levocetirizine in PER continuous versus on
      demand, measured by evolution of individual symptom scores during 6 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical history of Persistent allergic Rhinitis (PER) requiring treatment known at
             least since 2 years.

          -  Positive skin prick test (wheal > 3 mm larger than the diluent control) or Radio
             Allergo Sorbent Assay (RAST) (>= 3.5 IU/ml) to House Dust Mite (HDM) and Parietaria
             (less than 1 year).

          -  Minimum mean Total 4 Symptom Score (T4SS) of 6 over baseline period.

        Exclusion Criteria:

          -  Subjects currently treated by specific parietaria pollen immunotherapy

          -  Subjects suffering from non-allergic asthma

          -  Chronic use of inhaled steroids and/or long acting β2 agonists; and/or corticosteroids
             dependent asthma (severe asthma)

          -  Atopic dermatitis or urticaria requiring antihistamine treatment or the administration
             of oral or topical corticosteroids
Reducing Suicidal Ideation Through Treatment of Nightmares-Post Traumatic Stress Disorder (PTSD)
Condition: Post Traumatic Stress Disorder; Suicidal Ideation; Nightmares
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Suicidal Ideation
Intervention: Prazosin; Placebo
Intervention MeSH terms: Prazosin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Patients with PTSD, and frequent nightmares, and mild-moderate suicidal ideation, who are
      already taking a Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine
      Reuptake Inhibitor (SNRI) will be randomized to either prazosin or placebo. The investigators
      hypothesize that patients receiving prazosin will have a greater reduction in suicidal
      ideation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  PTSD

          -  Frequent nightmares

          -  Suicidality

        Exclusion Criteria:

          -  Schizophrenia

          -  Bipolar

          -  Substance abuse
Local Steroid Injection vs Placebo in Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Intervention: Methylprednisolone 80 mg; Methylprednisolone 40 mg; Saline
Intervention description: 2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine; 1 mL methylprednisolone (40 mg/mL) + 1 mL saline + 1 mL lidocaine; 2 mL saline + 1 mL lidocaine
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Between 2008 and 2012 the investigators performed a single-center randomized double-blind
      placebo-controlled trial to assess the efficacy of local injection of two different doses of
      methylprednisolone (80 mg and 40 mg) in patients with carpal tunnel syndrome (CTS), aged 18
      to 70 years, not previously treated with steroid injection. The primary outcomes were change
      in the CTS symptom severity score at 10 weeks and rate of carpal tunnel release surgery on
      the study hand at 1 year. In the trial 111 patients were randomized (37 in each of the 3
      groups: 80 mg methylprednisolone, 40 mg methylprednisolone and placebo) and all completed the
      1-year follow-up. The investiators plan an extended follow-up 5 to 7 years after injection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary idiopathic CTS

          -  Symptoms of classic or probable CTS according to the Katz diagnostic criteria
             (numbness and/or tingling in at least 2 of the 4 median nerve innervated fingers)

          -  Failed treatment with wrist splinting (2 months)

          -  Nerve conduction tests showing median neuropathy at the wrist or, if normal, two
             orthopedic surgeons independently make CTS diagnosis

          -  Symptom severity that warranted referral for consideration for surgery

        Exclusion Criteria:

          -  Previous steroid injection for CTS

          -  Thenar muscle atrophy

          -  Sensory deficit (two-point discrimination >8 mm)

          -  Diabetes, thyroid disorder, or inflammatory disease

          -  Polyneuropathy or vibration-induced neuropathy

          -  Current pregnancy

          -  Previous carpal tunnel surgery on the study hand

          -  Surgery on the contralateral hand in the past 2 months

          -  Inability to respond to questionnaires

          -  Severe medical illness

          -  Known drug/alcohol abuse
Effect of Mu-opioid Receptor Genetics on 3 Doses of Spinal Morphine for Postoperative Analgesia After Cesarean Section
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Morphine
Intervention description: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
Intervention MeSH terms: Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 169.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: cesarean; postoperative; morphine; genetics; opioid

Summary:

      HYPOTHESIS: The response to a given dose of morphine given via a spinal anesthetic for
      cesarean section will be affected by the genetics of the woman's mu-opioid receptor

      Most women undergoing elective cesarean section (CS) receive spinal anesthesia, and most
      receive a dose of preservative free morphine with the spinal anesthetic.
      Spinally-administered morphine provides 16-24 hours of high quality pain relief. The dose
      administered is usually 75-200 micrograms, but surprisingly few dose-response studies exist.

      The mu-opioid receptor (OPRM1 gene)is the site of action of endogenous opioid peptides and
      opioid analgesic drugs like morphine. There is a common genetic variant of this receptor at
      the 40th amino acid of the protein, with asparagine and asparate being present in different
      people. The less common variant (aspartate), present in 25-30% of the overall American
      population (higher in Asian populations, lower in Blacks) at codon 40 that has been shown in
      many studies to affect opioid analgesia.

      This will be a randomized, blinded study of 3 doses of spinal morphine (50, 100, 150
      micrograms) given to women undergoing elective cesarean section at term pregnancy. 300 women
      will be studied (100 per dose). Blood will be obtained for genotyping of OPRM1 and other
      genes that may affect pain and analgesic responses. The primary outcome will be the amount of
      intravenous morphine patients self-administer in the 24 hours postsurgery.

      The primary outcome (use of intravenous morphine) will be analyzed by dose, and within each
      dose group by genotype of OPRM1. Secondary outcomes will include pain scores every 6 hours,
      satisfaction with analgesia, side effects (itching, nausea/vomiting) by dose and genotype.

      It is anticipated that there will be an interim data analysis at 150 evaluable subjects for
      assessment of the dose response to morphine in the overall population; then a final analysis
      at 300 subjects for the genetic effect assessment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy women undergoing elective cesarean

        Exclusion Criteria:

          -  cardiovascular disease

          -  analgesic medications

          -  complications of pregnancy
Acute Headache Treatment in Pregnancy: Occipital Nerve Block vs PO Acetaminophen With Caffeine
Condition: Headache; Pregnancy Related; Occipital Nerve Block
MeSH terms: Headache
Intervention: Occipital Nerve Block
Intervention description: This is an open label randomized controlled trial evaluating response to bupivacaine occipital nerve block compared to Tylenol/Caffeine cocktail in treatment of pregnant patients seeking care of headache.
Intervention MeSH terms: Acetaminophen; Caffeine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled Trail
Masking: None (Open Label)
Enrollment: 62.0
Sex: Female
Minimum age: 16 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: headache; Pregnancy; Acute treatment; Emergency department; Occipital nerve block

Summary:

      This is an open label randomized controlled trial evaluating response to bupivacaine
      occipital nerve block compared to Tylenol/Caffeine cocktail in treatment of pregnant patients
      seeking care of headache.
    

Eligibility criteria:

        Inclusion criteria:

          1. Women presenting to Maternal Evaluation Unit at UAB hospital

          2. Confirmed live intrauterine pregnancy (previous ultrasound, bedside ultrasound, fetal
             monitoring)

          3. Complaint of headache

          4. Minimal pain level of 4 on VRS

        Exclusion criteria:

          1. Systolic BP >= 140 or diastolic BP>=90 with 1+ protein on urine dip

          2. Systolic BP >=160 or diastolic BP>=105

          3. Focal neurological symptoms

          4. Altered level of consciousness defined as not being oriented to person, place,
             situation, and/or year

          5. Complaint of seizure

          6. Known under lying brain abnormality

          7. Fever

          8. Use of >3 grams of acetaminophen in past 24hrs

          9. ONB in the past 3 months

         10. Reported allergy to study medications (Bupivacaine, acetaminophen, or caffeine)
Effect of Extended-release Oxymorphone Taken With or Without Food on Cognitive Functioning
Condition: Chronic Pain
MeSH terms: Chronic Pain
Intervention: Oxymorphone ER
Intervention description: 40 mg qd twice
Intervention MeSH terms: Oxymorphone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: opioid tolerant; chronic pain

Summary:

      The purpose of the study is to determine whether extended-release oxymorphone hydrochloride
      taken orally with a high-fat meal, generating an approximately 50% higher Cmax, impacts
      cognitive functioning, using Cambridge Neuropsychological Test Automated Battery (CANTAB)
      tests, to a greater extent than when taking under conditions of fasting.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Man or woman, 18-65 years of age, inclusive

          2. Able to provide informed consent and comply with all study procedures

          3. Women of childbearing potential with a negative urine pregnancy test at screening and
             on adequate contraception

          4. Chronic, non-malignant, painful condition, treated with long-acting opioid (methadone,
             OxyContin®, MS (Morphine Sulfate) Contin®, Kadian®, Avinza®, Fentanyl®, Opana® ER)

          5. Opioid treatment for at least 3 months prior to screening at a minimum dose of 90 mg
             of morphine equivalents per day or 50 mcg of the fentanyl transdermal patch

          6. Dose of opioid treatment stable for at least 1 week prior to screening and expected to
             be stable from screening through end of second testing

          7. Weight at screening 100-300 pounds, inclusive

        Exclusion Criteria:

          1. Pregnant or breastfeeding

          2. Gastrointestinal disorder or S/P gastrointestinal surgery impacting absorption of
             study medication (delayed gastric emptying, partial or complete gastrectomy)

          3. Alcohol or substance abuse within 2 years of screening

          4. Consumption of alcohol within 24 hours of a screening or testing visit

          5. Consumption of xanthine-containing beverages (coffee, tea, coke) on the morning of a
             screening or testing visit

          6. Impaired kidney or liver function (transaminase levels more than 3 times elevated;
             estimated creatinine clearance less than 50 mL/min)

          7. Epworth sleepiness scale (ESS) score 16 or higher at screening

          8. Medically concerning hypertension (≥ 160/100) or unstable cardiovascular illness

          9. Any clinically significant illness that would interfere with study participation or
             put the subject at risk

         10. Exposure to investigational medication within 30 days of screening
Efficacy and Safety Study of Empagliflozin as add-on to Insulin in Japanese Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Empagliflozin; Placebo; Placebo
Intervention description: For blinding purposes
Intervention MeSH terms: Empagliflozin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 269.0
Sex: All
Minimum age: 20 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      This is a multi-center, randomised, double-blind, placebo-controlled, parallel-group,
      efficacy and safety study of empagliflozin as add-on to insulin in Japanese patients with
      Type 2 Diabetes Mellitus with insufficient glycaemic control
    

Eligibility criteria:

        Inclusion criteria:

          -  Diagnosis of type 2 diabetes mellitus

          -  Patients on diet and exercise regimen who are pre-treated with any insulin therapy
             alone or in combination with 1 oral antidiabetic drug for at least 12 weeks prior to
             screening

          -  Fasting C-peptide must be > 0.5 ng/mL

          -  HbA1c at screening in Patients who are treated with insulin alone must be >=7.5% and
             <=10.0%

          -  HbA1c in Patients who are treated with insulin with 1 oral antidiabetic drug (OAD)
             must be >=7.0% and <=9.5% at screening, and >=7.5% and <=10.0% at placebo run-in
             period

          -  Age at informed consent must be >=20 and <75 years

          -  BMI at screening must be >22 and <=40 kg/m2

          -  Further inclusion criteria apply

        Exclusion criteria:

          -  Patients who experience uncontrolled hyperglycaemia before randomization

          -  Patients who are treated with sulfonylurea whose dose is more than a half of daily
             maximum approval dose, glucagon-like peptide-1 (GLP-1) analogue, thiazolidinedione and
             sodium-glucose co-transporter 2 (SGLT-2) inhibitor

          -  Patients with recent cardiovascular and/or stroke events

          -  Patients with hepatic and/or renal dysfunction

          -  Patients who received anti-obesity drugs or other treatment leading to unstable body
             weight

          -  Patients who have known allergy or hypersensitivity to insulin and/or empagliflozin

          -  Pre-menopausal women who are nursing or pregnant

          -  Further exclusion criteria apply
A Study of the Glucodynamic Effects of Dulaglutide (LY2189265) in Japanese Participants With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Dulaglutide; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Dulaglutide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 12.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the glucodynamic effects of dulaglutide in Japanese
      participants with type 2 diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have type 2 diabetes (based on the World Health Organization [WHO] diagnostic
             criteria) for at least 1 year.

          -  Have diet and exercise therapy only (no oral antihyperglycemic medication for at least
             3 months prior to screening).

          -  Have a fasting blood glucose value of ≥120 and ≤200 milligrams per deciliter (mg/dL)
             at screening.

          -  Have a screening body weight of ≥50 and ≤80 kilograms.

        Exclusion Criteria:

          -  Have known allergies to dulaglutide, or other glucagon-like peptide-1 (GLP-1) receptor
             agonists.

          -  Have had a clinically significant cardiovascular disease.

          -  Have a known clinically significant gastric emptying abnormality or have undergone
             gastric bypass surgery or restrictive bariatric surgery.

          -  Have acute or chronic hepatitis, signs and symptoms of any other liver disease.

          -  Have a history of chronic pancreatitis or acute idiopathic pancreatitis, or were
             diagnosed with any type of acute pancreatitis.

          -  Have an estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 meter
             squared.

          -  In the opinion of the investigator or sponsor, are unsuitable for inclusion in the
             study.
Methadone in Pediatric Anesthesia
Condition: Anesthesia
Intervention: Methadone 0.1mg/kg; Methadone 0.2mg/kg; Methadone 0.3mg/kg; Control
Intervention description: Subjects will receive methadone as their intraoperative opioid.; Subjects will receive methadone as their intraoperative opioid.; Subjects will receive methadone as their intraoperative opioid.; Subjects will not receive methadone as their intraoperative opioid.
Intervention MeSH terms: Methadone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 5 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Pediatric patients undergoing surgery

Summary:

      This study will determine the pharmacokinetics of intravenous (IV) methadone in children
      undergoing surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 5-18

          -  Undergoing General anesthesia and surgery with anticipated postoperative inpatient
             stay of greater than or equal to 3 days

          -  Signed, written, informed consent from legal guardians and assent from patient

        Exclusion Criteria:

          -  History of or known liver or kidney disease