bioihbjkbjnl/mcl2 huggingface dataset:
Spinal Cord Stimulation (SCS) Dosing Study
Condition: Back Pain; Leg Pain
MeSH terms: Back Pain
Intervention: Spinal Cord Stimulation
Intervention description: Programming
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: 22 Years
Healthy volunteers: No

Summary:

      This study characterized the effects of amplitude on subject satisfaction and pain relief in
      subjects being treated by SCS.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 22 years of age or older

          2. Implanted with a RestoreSensor system (for back and leg pain) for at least 1 month

          3. Has approproate SCS settings

          4. Willing and able to provide signed and dated informed consent

          5. Capable of comprehending and consenting in English

          6. Capable of getting into the supine and sitting positions

          7. Willing and able to comply with all study procedures and visits

          8. On stable (no change in dose, route, or frequency) prescribed pain medications

        Exclusion Criteria:

          1. Implanted with leads for peripheral nerve stimulation or an implantable intrathecal
             drug delivery system

          2. Had a pain-related surgery in the previous 1 month of enrollment or the intent to
             undergo surgery during the period of the study

          3. Implanted with quadripolar lead

          4. Currently enrolled or planning to enroll in a potentially confounding clinical study
             during the course of the study

          5. Pregnant or is of child-bearing potential and unwilling to use a medically acceptable
             form of birth control during the study

          6. Has untreated major psychiatric comorbidity

          7. Has serious drug-related behavioral issues

          8. Has unresolved major issues of secondary gain
A Novel Analgesia Technique for ACL Reconstruction
Condition: Anterior Cruciate Ligament Injury
MeSH terms: Anterior Cruciate Ligament Injuries
Intervention: Bupivacaine; Ultrasound; Dexamethasone
Intervention description: Bupivacaine will help treat pain and sensation after ACL repair; Ultrasound will guide anesthesiologist in performing the different nerve blocks; Dexamethasone will be used to prolong block duration
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Bupivacaine; BB 1101
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 78.0
Sex: All
Minimum age: 13 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      A comparison of two anesthetic techniques-- the Adductor Canal Block (ACB) and the Adductor
      Canal Block with Infiltration of the interspace between the popliteal artery and the capsule
      of the posterior knee (ACB/IPACK)-- in patients undergoing bone-tendon-bone (BTB) anterior
      cruciate ligament (ACL) reconstruction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing BTB ACL reconstruction with participating surgeon

          -  Age 13 or greater

          -  Planned use of regional anesthesia

          -  Ability to follow study protocol

          -  English speaking (secondary outcomes include questionnaires validated in English only)

        Exclusion Criteria:

          -  Hepatic or renal insufficiency

          -  Younger than 13 years old

          -  Patients undergoing general anesthesia

          -  Allergy or intolerance to one of the study medications

          -  BMI > 40

          -  Diabetes

          -  American Society of Anesthesiology (ASA) score IV

          -  Chronic gabapentin/pregabalin use (regular use for longer than 3 months)

          -  Chronic opioid use (taking opioids for longer than 3 months, or daily morphine
             equivalent of >5mg/day for one month)

          -  Non-English speaking
The Effects of Sacubitril/Valsartan on Cardiac Oxygen Consumption and Efficiency of Cardiac Work in Heart Failure Patients
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: sacubitril/valsatran; valsartan; placebo to valsartan; placebo to sacubitril/valsartan
Intervention description: sacubitril/valsatran 100 or 200 mg BID; Valsartan 80 or 160 mg BID; placebo to valsartan 80 or 160 BID; placebo to sacubitril/valsartan 100 or 200 mg BID
Intervention MeSH terms: Valsartan; Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 55.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Heart failure with reduced left ventricular ejection fraction; LVEF; Cardiac dysfunction; Heart muscle dysfunction; Left ventricular (LV) dilation; Left ventricular hypertrophy; HF; AHF; CHF; CCF; acute heart failure; chronic heart failure; congestive heart failure; congestive cardiac failure

Summary:

      This is a phase IV, prospective, randomized, double-blind, double-dummy, parallel-group
      study.

      The study assessed the effects of 6 weeks of stable sacubitril/valsartan therapy, as compared
      with valsartan therapy, on the efficiency of cardiac work in patients with NYHA II-III heart
      failure (HF) and reduced systolic function using 11C-acetate positron emission tomography
      (PET) and echocardiography.
    

Eligibility criteria:

        Inclusion criteria:

          -  40-80 years of age

          -  Chronic HF with reduced EF (left ventricle EF 25-35%) and NYHA class II-III symptoms.

          -  Systolic BP 110-160 mm Hg

          -  Optimal standard HF therapy according to European Society of Cardiology (ESC)
             guidelines at a stable dose for at least 4 weeks before the screening visit.

        Exclusion criteria:

          -  Estimated glomerular filtration rate (eGFR) < 45 ml/min

          -  Serum potassium > 5.2 mmol/l and creatinine >1.5 x ULN
Mechanisms Underlying Metabolic Syndrome in Obesity
Condition: Metabolic Syndrome; Insulin Resistance; Prediabetes
MeSH terms: Obesity; Metabolic Syndrome; Insulin Resistance; Syndrome
Intervention: Pioglitazone
Intervention description: Pioglitazone 30mg for 2 weeks, then Pioglitazone 45mg for 8 weeks.
Intervention MeSH terms: Pioglitazone
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: obesity; inflammation; diabetes

Summary:

      The purpose of this study is to better understand the link between obesity and diabetes or
      pre-diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-65 years of age

          -  BMI 28+

          -  diabetes, impaired glucose tolerance or normal glucose tolerance

        Exclusion Criteria:

          -  AST >2x normal

          -  congestive heart failure

          -  history of coronary artery disease

          -  chronic renal insufficiency (creatinine > 1.4mg/dl)

          -  use of gemfibrozil, ACE inhibitors, and angiotensin receptor II blockers, or
             anticoagulants
The Effectiveness of Nasal Corticosteroids Versus Placebo in Nasal Obstruction in Patients With Nasal Septal Deviation
Condition: Nasal Obstruction
MeSH terms: Nasal Obstruction
Intervention: Triamcinolone Acetonide; Ayr saline nasal mist
Intervention description: 2 sprays sprayed to both nostrils daily for 42 days.; 110mcg (2 sprays) sprayed to both nostrils daily for 42 days.
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      The purpose of this project is to determine if intranasal corticosteroids have an effect on
      nasal obstruction in patients with nasal septal deviation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age greater than 18

          -  NOSE score greater than 55

          -  Nasal septal deviation on exam

        Exclusion Criteria:

          -  Intranasal steroid use within the last three months

          -  Current systemic steroid use

          -  Prior septal surgery

          -  Individuals who are pregnant or actively breastfeeding
Anti Propionibacterium(P.) Acnes Activity of Epiduo® Gel Compared to Benzoyl Peroxide (BPO) 2.5% Gel
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Epiduo gel; BPO
Intervention description: Once daily application on the face in the evening for 12 weeks; Once daily application on the face in the evening for 12 weeks
Intervention MeSH terms: Adapalene, Benzoyl Peroxide Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: P. acnes, Acne vulgaris

Summary:

      The purpose of this study is to evaluate the antibacterial activity of Epiduo® Gel (Adapalene
      0.1% / Benzoyl Peroxide 2.5% Gel) on P. acnes compared to that of Benzoyl Peroxide 2.5% Gel.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with facial acne,

          -  Subjects with high levels of P. acnes counts on the forehead

        Exclusion Criteria:

          -  Female Subjects who are pregnant, nursing or planning a pregnancy during the study,

          -  Subjects with acne conglobata, acne fulminans, secondary acne

          -  Subjects with known or suspected allergy to one of the test product
Single Versus Combination Medication Treatment for Children With Attention Deficit Hyperactivity Disorder
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Guanfacine; Methylphenidate (MPH)
Intervention description: Week 1: 0.5 mg twice daily; Week 2: 1 mg twice daily; Week 3: 1.5 mg twice daily; Weeks 4 through 8: best dose as determined by efficacy measures; Participants less than 25 kg will receive 10 mg once daily for Week 5, 20 mg once daily for Week 6, and 30 mg once daily for Week 7. Subjects greater than 25 kg will receive 20 mg once daily for Week 5, 30 mg once daily for Week 6, 40 mg once daily for Week 7, and best doses as determined by efficacy measures for Week 8.
Intervention MeSH terms: Guanfacine; Methylphenidate; Dexmethylphenidate Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 212.0
Sex: All
Minimum age: 7 Years
Maximum age: 14 Years
Healthy volunteers: No
Keywords: ADHD; Guanfacine; Methylphenidate; Focalin XR; Pediatric; Cognitive function; Combination therapy

Summary:

      This study will evaluate the effectiveness of a single drug versus a combination of drugs in
      treating attention deficit hyperactivity disorder in children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of DSM-IV ADHD by K-SADS-PL and confirmed by clinical interview

          -  Clinical Global Impression-Severity score of at least 4 for ADHD

          -  Resided with primary caretaker for at least 6 months prior to study entry

        Exclusion Criteria:

          -  History of autism, pervasive developmental disorder, chronic tic disorder, psychosis,
             or bipolar disorder

          -  Current major depression or panic disorder

          -  Systolic or diastolic blood pressure at screening greater than the 95th percentile or
             less than the 5th percentile for age and body mass index (BMI)

          -  Any medical condition that might make stimulant or alpha agonist therapy medically
             inadvisable

          -  Need for chronic use of other medications with central nervous system effects

          -  Pregnant, breastfeeding, or beyond menarche and has a positive urine pregnancy test

          -  History of structural heart defects, syncope, or fainting while exercising

          -  Clinically significant cardiac abnormality as determined by echocardiogram (ECG) at
             study entry

          -  Mental retardation as determined by clinical functional assessment and an IQ estimate
             of less than 70 based on Wechsler Adult Intelligence Scale (WAIS) subtests
Study of Rhopressa® for the Reduction of Elevated Intraocular Pressure in Patients With Glaucoma or Ocular Hypertension in a Real-world Setting
Condition: Glaucoma, Open-Angle; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Glaucoma, Open-Angle; Hypertension
Intervention: Netarsudil Ophthalmic Solution 0.02%
Intervention description: 1 drop in each eye once daily in the evening
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 261.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the IOP lowering efficacy of netarsudil ophthalmic solution 0.02% when used as
      monotherapy or when used concomitantly with other IOP-lowering agents in subjects with
      elevated IOP due to open angle glaucoma or ocular hypertension in a real-world clinical
      setting. The study is an open-label design. The patients will receive treatment for 12 weeks.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Male or female subjects (aged 18 or older)

          2. Subjects diagnosed with open-angle glaucoma or ocular hypertension, and determined by
             the treating physician to require additional intraocular pressure (IOP)-lowering
             treatment with netarsudil 0.02%.

          3. Willingness to follow protocol requirements, including signed informed consent,
             routine follow-up schedule, completing questionnaires and completing laboratory tests

        Key Exclusion Criteria:

          1. Have any active ocular disease other than glaucoma or ocular hypertension that would
             interfere with study interpretation

          2. Women of childbearing potential who are pregnant, nursing, or planning a pregnancy and
             not using a medically acceptable form of birth control. Male subjects with a female
             partner of childbearing potential must have had a prior vasectomy or agree to use an
             effective method of birth control during the treatment period and for 3 months after
             the subject has completed the study.

          3. Known sensitivity or allergy to the study medication or components

          4. Any systemic disease or clinical evidence of any condition which would make the
             subject, in the opinion of the investigator, unsuitable for the study or could
             potentially confound the study results

          5. Concurrent participation or prior participation in any investigational drug or device
             study within the last 30 days prior to the Baseline Visit
The Effect of Dexmedetomidine on Airway Complications After Deep or Awake Extubation
Condition: Adenotonsillar Hypertrophy; Obstructive Sleep Apnea; Tonsillitis; Adenoiditis
MeSH terms: Tonsillitis; Sleep Apnea, Obstructive; Hypertrophy
Intervention: Normal Saline; Dexmedetomidine
Intervention description: to arms 2,4. Serves as the placebo.; to arms 1,3
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 92.0
Sex: All
Minimum age: 3 Years
Maximum age: 16 Years
Healthy volunteers: No

Summary:

      The investigators aim to investigate the effect of dexmedetomidine on the perioperative
      respiratory complications in this patient population undergoing both awake and deep tracheal
      extubation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients between 3 to 16 years of age undergoing adenotonsillectomy, with or without
             myringotomy or myringoplasty

          -  ASA 1 & 2

        Exclusion Criteria:

          -  Known allergy or hypersensitivity reaction to dexmedetomidine

          -  Organ dysfunction (renal/hepatic failure or leukemia)

          -  Cardiac disease (congenital or acquired)

          -  Airway or thoracic malformation

          -  Cerebral palsy

          -  Hypotonia

          -  Need for premedication

          -  Current/recent upper respiratory infection (within four weeks prior to the surgery)

          -  Asthma

          -  Allergy or intolerance to clonidine

          -  Non-English speaking parents/patients.
rtPA in in the Prevention of CVAD-Associated Thrombosis and Infection in Pediatric Patients With Short Bowel Syndrome
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Thrombosis; Syndrome
Intervention: rtPA lock therapy
Intervention description: rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks. rtPA will be given as research intervention as "lock therapy" in that it will dwell within the catheter of the CVAD for a specified duration of time and then be removed (aspirated); in this setting the medication is not given to the patient as a flush, i.e. in systemic fashion.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 6 Months
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      The primary research question is, in patients with short bowel syndrome requiring central
      venous access device (CVAD) for long-term total parenteral nutrition, is once weekly
      recombinant tissue plasminogen activator (rtPA) lock therapy more effective than routine care
      using heparin flushes in reducing the incidence of line-associated thrombosis and infection.
    

Eligibility criteria:

        Inclusion Criteria:

          1. subjects with short bowel syndrome

          2. requirement for central venous access device (CVAD) for long-term TPN administration

          3. age >/= 6 months to < 16 years

          4. ability to initiate rtPA during hospitalization for newly inserted CVAD

          5. ability to be enrolled within 48 hours of CVAD placement.

        Exclusion Criteria:

          1. platelet count <50,000

          2. active bleeding

          3. age =/> 16 years at time of consent.
Safety of PATANASE Nasal Spray in Patients With Perennial Allergic Rhinitis
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: Olopatadine hydrochloride 0.6% nasal spray (PATANASE); Olopatadine nasal spray vehicle, pH 3.7; Olopatadine nasal spray vehicle, pH 7.0
Intervention description: Two sprays in each nostril twice a day (morning and evening) for up to 12 months; Two sprays in each nostril twice a day (morning and evening) for up to 12 months; Two sprays in each nostril twice a day (morning and evening) for up to 12 months
Intervention MeSH terms: Olopatadine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1260.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: nasal allergy; nasal spray; seasonal allergy; perennial allergy

Summary:

      The purpose of this study was to assess local nasal adverse effects, as well as systemic
      effects, of PATANASE nasal spray when compared with Patanase Vehicle, pH 3.7 and Patanase
      Vehicle, pH 7.0 in patients with perennial allergic rhinitis (PAR).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Sign informed consent;

          2. Normal nasal exam;

          3. History of perennial allergic rhinitis;

          4. Allergy to perennial allergen documented by allergy testing;

          5. Age 12 years and older;

          6. Must follow instructions;

          7. Must make required study visits;

          8. Negative pregnancy test and adequate birth control methods for females of childbearing
             potential;

          9. Refrain from certain allergy medications during the study;

         10. Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          1. Nasal disorders;

          2. Use of substances that affect the nasal septum;

          3. Exposure to industrial metal plating solutions;

          4. Uncontrolled, severe, or unstable diseases;

          5. Hypersensitivity to the study drug or nasal spray components;

          6. Relative of site staff with access to the protocol;

          7. Participation in another investigational study within 30 days or at the same time as
             this study;

          8. Medical Monitor decision;

          9. Other protocol-defined exclusion criteria may apply.