bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Intramuscular Oxytocin on Sensory Function in Healthy Volunteers With Ultraviolet Burn Injury to the Skin
Condition: Chronic Pain
MeSH terms: Chronic Pain
Intervention: Oxytocin; Saline
Intervention description: 10 IU oxytocin (Pitocin) for intramuscular injection; 1.5 ml preservative free saline for intramuscular injection
Intervention MeSH terms: Oxytocin
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double blinded crossover treatment with oxytocin and placebo (saline)
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Participant, Investigator and outcomes assessor will be blinded. Research Pharmacist will prepare the study medication administration and hold the randomization.
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study proposes to evaluate the effects that a dose of oxytocin given by intramuscular
      (IM) injection (into the muscle) will have on an area of skin that has been exposed to
      ultraviolet (UV) light. The area of skin exposed to UV light will have a mild sun burn
      feeling.

      Sensory testing will be performed on the area of UV burn. The area will be evaluated for
      sensitivity in 3 methods: touch, vibratory
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female > 18 and < 60 years of age,

          -  Body Mass Index (BMI) <40

          -  Generally in good health as determined by the Principal Investigator based on prior
             medical history

          -  Normal blood pressure and resting heart rate without medication

        Exclusion Criteria:

          -  Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin®

          -  Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the
             Principal Investigator, would place the subject at increased risk

          -  Women who are pregnant (positive result for serum pregnancy test at screening visit),
             women who are currently nursing or lactating, women that have been pregnant within 2
             years.

          -  Neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain
             medications on a daily basis.
Early Versus Routine Caffeine Administration in Extremely Preterm Neonates
Condition: Caffeine
Intervention: Caffeine
Intervention description: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 2 hours of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose.
Intervention MeSH terms: Caffeine; Caffeine citrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 21.0
Sex: All
Healthy volunteers: No
Keywords: caffeine; intubation; hemodynamic

Summary:

      Premature infants are at risk of having pauses in breathing, or apneas, due to their
      immaturity. Premature infants are routinely given caffeine, a respiratory stimulant, on the
      first day of life to prevent apneas. However, if they continue to have apneas, they may
      require a breathing tube to be placed in the trachea. There are risks to having a breathing
      tube, so it would be beneficial to avoid it if possible. If caffeine is given earlier, it may
      decrease the need for a breathing tube. Some studies also suggest that caffeine may also
      improve heart function which may prevent low blood pressure if given early.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any infant delivered at Sharp Mary Birch Hospital between 23 and 28 6/7 weeks;
             gestation

        Exclusion Criteria:

          -  Any infant with a major congenital anomaly including airway anomalies, congenital
             diaphragmatic hernia, or hydrops

          -  Any infant with a known or a discovered major cardiac defect other than a patent
             ductus arterious (PDA), patent foramen ovale (PFO), or small ventricular septal defect
             (VSD)

          -  Inability to place a peripheral IV after two attempts. Severe apnea or bradycardia in
             the first 60 minutes of life requiring emergent endotracheal intubation.
Short-Term Effects & Safety of an Accelerated Intravenous Iron Regimen in Patients With Heart Failure
Condition: Heart Failure; Iron Deficiency Anemia
MeSH terms: Heart Failure; Anemia, Iron-Deficiency; Iron Deficiencies
Intervention: Sodium ferric gluconate
Intervention description: Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
Intervention MeSH terms: Ferric gluconate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Intravenous iron replacement has been shown to benefit patients with heart failure and iron
      deficiency, but the weekly outpatient regimens studied to date are impractical for many
      patients. Our purpose is to evaluate the short-term effects and safety of an accelerated
      intravenous iron regimen in hospitalized patients with these two conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 years

          -  Admission to the general cardiology or heart failure services and under the care of a
             cardiologist at the study institution

          -  New York Heart Association Class II-IV heart failure

          -  Ejection fraction < 40%

          -  Serum hemoglobin < 12.0 g/dL

          -  Ferritin < 100 ng/mL or 100-300 ng/mL with transferrin saturation (TSAT) < 20%

          -  Patients deemed by an attending physician to require intravenous iron therapy based on
             previous attempts to correct iron deficiency or other patient-specific circumstances

        Exclusion Criteria:

          -  Anemia of other known etiology (e.g., malignancy, malabsorption syndromes)

          -  Use of iron or erythropoietin-stimulating agents within previous 12 weeks

          -  Blood transfusion within previous 12 weeks; additionally, if patients receive blood
             transfusions during the study period, they will remain in the safety analysis but will
             be excluded from efficacy analysis

          -  Active bleeding

          -  Known infection at admission

          -  Immunosuppressant therapy

          -  Renal replacement therapy

          -  Known pregnancy

          -  Any other criteria deemed by the attending physician to warrant exclusion
Does Low-does Cervical Epidural Lidocaine Cause Transient Weakness?
Condition: Cervical Radiculopathy
MeSH terms: Radiculopathy; Asthenia
Intervention: cervical interlaminar with lidocaine; cervical interlaminar with normal saline; Lidocaine; Triamcinolone Acetonide; Normal saline
Intervention description: Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL 1% lidocaine.; Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL preservative saline; 2 mL lidocaine to be used as steroid diluent in group #1 cervical interlaminar procedure.; 2 mL of 40 mg/mL will be used as the steroid in group #1 and group #2 cervical interlaminar procedures.; 2 mL of normal saline to be used as steroid diluent in group #2 cervical interlaminar procedure.
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Lidocaine; Triamcinolone diacetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Masking description: Each subject will be randomized into a group assignment in a 1:1 manner, #1 or #2, as outlined in the Methods section.
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: cervical epidural steroid injection; local anesthetic; upper extremity weakness

Summary:

      "Does low-does cervical epidural lidocaine cause transient weakness?"
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18-80.

          2. Clinical diagnosis of cervical radicular pain.

          3. Magnetic resonance imaging pathology consistent with clinical symptoms/signs.

          4. Numerical Rating Scale (NRS) pain score of 4 or higher.

          5. Pain duration of more than 6 weeks despite trial of conservative therapy (medications,
             physical therapy, or chiropractic care).

          6. Patients who will undergo CESI for treatment of cervical radiculitis.

        Exclusion Criteria:

          1. Refusal to participate, provide consent, or provide communication and follow-up
             information for duration of the study.

          2. Inability to perform handgrip or arm strength testing.

          3. Contraindications to Cervical ESI (active infection, bleeding disorders, current
             anticoagulant or antiplatelet medication use, allergy to medications used for CIESI,
             and pregnancy).

          4. Current glucocorticoid use or ESI within past 6 months.

          5. Prior cervical spine surgery.

          6. Cervical spinal cord lesions; cerebrovascular, demyelinating, or other neuro-muscular
             muscular disease.

          7. Patient request for or requirement of conscious sedation for the injection procedure.
Are NSAIDs Effective Enough for Postoperative Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty
Condition: Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty
MeSH terms: Pain, Postoperative
Intervention: diclofenac; Norco
Intervention description: The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.; The opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).
Intervention MeSH terms: Acetaminophen; Diclofenac; Hydrocodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the level of pain control in patients receiving
      non-steroidal anti-inflammatory drugs (NSAIDs) to those receiving opioids in the
      postoperative period after endoscopic sinus surgery (ESS) and/or septoplasty.
    

Eligibility criteria:

        Inclusion Criteria:

          -  english speaking

          -  candidates for endoscopic sinus surgery as determined by medical necessity by the
             treating rhinologist

          -  scheduled for surgery at Texas Sinus Institute

        Exclusion Criteria:

          -  allergy to either NSAIDs or opioids

          -  contraindication to NSAIDs (ex. gastritis, chronic kidney disease)

          -  surgical plan exceeding basic endoscopic sinus surgery

          -  use of anticoagulation

          -  the presence of any pain disorder

          -  the current usage of any analgesic medication

          -  history of opioid addiction

          -  pregnancy

          -  history of chronic pain or fibromyalgia

          -  current daily use of NSAIDs, acetaminophen, opioids or other analgesics (pregabalin,
             tramadol, etc)
Botulism Toxin Injection as a Treatment for Arthritis of the Basal Thumb Joint
Condition: Arthritis Multiple Joint
MeSH terms: Arthritis
Intervention: Botulinum Toxin Type A; Steroid - Triamcinolone Acetonide; Lidocaine
Intervention description: One-time injection of 50 units of Botulinum Toxin A suspended in 2 mL of normal saline, with approximately 1 mL injected or sufficient quantity to fill joint capsule; Single injection of 1 - 3 mL of 40mg/mL Triamcinolone acetonide solution; Single injection of 1 - 3 mL of 2% Lidocaine
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Lidocaine; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; Triamcinolone diacetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Carpometacarpal Joints; Osteoarthritis; Basal thumb joint arthritis; Trapeziometacarpal arthritis

Summary:

      Basal arthritis of the thumb is a common condition with increased prevalence in
      post-menopausal women, obese persons, and the elderly. Surgical options are varied and
      efficacious, but not all patients are candidates for surgery. The successes and pitfalls of
      previous, similar trials are carefully considered in the creation of our own. Though steroid
      injection is the standard of care in basal joint arthritis, current data does not support its
      efficacy beyond placebo effect. No trial has yet examined the efficacy of botulinum toxin
      type A (BTX-A) injection into the basal thumb joint nor compared it to steroid. Since
      efficacy of steroid is questionable at best, our hope is that BTX-A injection of the basal
      joint might be the next great tool in treating this common, debilitating disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Radiographic evidence of basal joint arthritis

          -  Associated symptoms of basal joint arthritis including:

          -  Pain

          -  Decreased range of motion

          -  Decreased thumb strength

        Exclusion Criteria:

          -  Persons under the age of 18

          -  Women who are currently pregnant

          -  Incompetent persons or persons otherwise incapable of effectively communicating the
             subjective experience of pain

          -  Prior surgery on the joint

          -  Injection in the last 12 months
Buspirone Treatment for Marijuana Dependence
Condition: Marijuana Dependence
MeSH terms: Marijuana Abuse
Intervention: Buspirone; Placebo
Intervention description: Flexible dose, up to 60 mg daily; Flexible dose, up to 60 mg daily
Intervention MeSH terms: Buspirone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 175.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Marijuana; Buspirone; Contingency management; Motivational enhancement therapy

Summary:

      Marijuana is the most commonly used illicit drug, yet few clinical trials have evaluated
      pharmacotherapy treatments for marijuana dependence. This study will evaluate the efficacy of
      buspirone for reducing marijuana use in marijuana-dependent adults. A contingency management
      (CM) intervention and motivational enhancement therapy (MET) will be incorporated to
      encourage study engagement and retention. It is hypothesized that buspirone combined with MET
      and CM will reduce the percent of marijuana-positive urine drug screen results in
      marijuana-dependent individuals as compared to a placebo treatment combined with MET and CM.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must meet DSM-IV criteria for marijuana dependence.

          -  Must be between the ages of 18 and 65 years.

          -  If female and of childbearing potential, must agree to use acceptable methods of birth
             control for the duration of the trial.

          -  Must consent to random assignment, and be willing to commit to psychosocial behavioral
             and medication treatment.

          -  Must be able to read and provide informed consent.

        Exclusion Criteria:

          -  Women who are pregnant, nursing, or plan to become pregnant during the course of the
             study.

          -  Must not have a history of or current psychotic disorder, bipolar disorder, or eating
             disorder.

          -  Must not pose a current suicidal or homicidal risk.

          -  Must not meet current criteria for major depression.

          -  Must not have evidence or history of serious hematologic, endocrine, cardiovascular,
             pulmonary, renal, gastrointestinal or neurologic disease.

          -  Must not require concomitant therapy with psychotropic medication.

          -  Must not be currently dependent on other substances, with the exception of nicotine or
             caffeine.

          -  Hypersensitivity to buspirone or any other product component.

          -  Patients who, in the investigator's opinion, would be unable to comply with study
             procedures or assessments, or would be unacceptable study candidates (e.g., poses
             threat to staff).
Safety of Remifentanil Infusion
Condition: Urinary Tract Problem
Intervention: remifentanil
Intervention description: 1-4 ng/mL i.v. infusion during the surgery, maintenance dosage till LMA removal is 1.5 ng/mL.
Intervention MeSH terms: Remifentanil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Remifentanil; Laryngeal mask airway removal; Hemodynamic changing; Infusion; Ureterorenoscopy

Summary:

      The effect of maintenance remifentanil infusion with target controlled infusion during
      laryngeal mask airway removal on hemodynamic parameters and emergence quality is going to be
      investigated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA I-II status

          -  aged 18-60 years old

          -  presenting for ureterorenoscopy

        Exclusion Criteria:

          -  history of hypertension

          -  asthma and chronic obstructive lung disease

          -  recent respiratory tract infections
Long-Term Growth and Skeletal Effects of Early Growth Hormone Treatment in Turner Syndrome
Condition: Turner Syndrome
MeSH terms: Turner Syndrome; Gonadal Dysgenesis; Syndrome
Intervention: Humatrope
Intervention description: According to investigator's clinical practice and guided by the approved package insert
Intervention MeSH terms: Hormones
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 69.0
Sex: Female
Minimum age: 4 Years
Maximum age: 20 Years
Healthy volunteers: No

Summary:

      This is an extension study that will gather long-term data on the effect of early growth
      hormone (GH) treatment on adult height and other aspects of health and development in girls
      with Turner syndrome. The main purpose is to determine whether girls who received 2 years of
      GH treatment before 6 years of age achieve taller adult height than girls who were untreated
      during this time. The study will also look at middle ear and hearing function, and cognitive
      and behavioral development. Protocol completion is defined as attainment of height velocity
      less than or equal to 1.0 cm/year, or bone age greater than or equal to 15 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previously randomized in study B9R-US-GDFG (NCT00406926)

          -  Karyotype-proven Turner syndrome

        Exclusion Criteria:

          -  Immediate family members of study site personnel directly affiliated with the study
Evaluation of Quality of Life, Efficacy, and Tolerance of Duac® Gel Compared to Differin® Gel in the Treatment of Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Duac Gel; Differin gel
Intervention description: Duac® Gel will be applied to the face once daily at night, for 12 weeks.; Differin Gel will be applied to the face once daily at night, for 12 weeks.
Intervention MeSH terms: Adapalene
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 169.0
Sex: All
Minimum age: 12 Years
Maximum age: 39 Years
Healthy volunteers: No
Keywords: Differin; quality of life; Acne; Duac; Acne Vulgaris

Summary:

      The objectives of this clinical trial are to compare the quality of life of the subjects, the
      efficacy and the tolerance of Duac® Gel (gel formulation with a combination of clindamycin
      phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide), applied once daily,
      against Differin® Gel (gel with 0.1% adapalene), used once daily, in the treatment of mild to
      moderate acne vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with mild to moderate acne vulgaris on the face,.

          -  Subjects of either sex aged between 12 and 39 years, inclusive.

          -  Subjects agreeing not to use sun-beds or undergo any UV light treatment for 4 weeks
             prior to entering the study and to minimize the amount of exposure to direct sunlight
             for the duration of the study.

        Exclusion Criteria:

          -  Women who are pregnant, breast-feeding, or sexually active with the potential to have
             children, and not using a contraception method that is safe from a medical point of
             view

          -  Subjects using anti-androgen containing contraceptives.

          -  Subjects who, during the past month, have received oral or topical steroids or
             antibiotics, or acne treatment of any type, including natural or artificial UV
             therapy.

          -  Subjects who have a history of hypersensitivity or idiosyncratic reaction to
             clindamycin phosphate, benzoyl peroxide, adapalene or any components of the medicinal
             products which will be used during the study.

          -  Subjects using, or having used in the past month, any significant concomitant
             medicinal product which might affect their acne, as judged by the Investigator.

          -  Subjects with a history of regional enteritis or ulcerative colitis, or a history of
             antibiotic-associated colitis.

          -  Subjects with a history of photosensitivity.