bioihbjkbjnl/mcl2 huggingface dataset:
Buprenorphine as a Treatment in Opiate Dependent Pain Patients
Condition: Opiate Addiction; Refractory Pain
MeSH terms: Pain, Intractable; Opioid-Related Disorders
Intervention: buprenorphine/naloxone; buprenorphine/naloxone
Intervention description: sublingual tablets, 2/0.5 mg, three times a day for one month, twice a day for one month, once a day for one month, then every other day for one month. (dose may be adjusted based on an individual's response); sublingual tablets, 2/0.5 mg, one tablet three times a day for six months (doses may be adjusted based on an individual's response
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: drug dependence; substance abuse; substance use disorders; myofascial pain syndrome; neuralgia; back pain

Summary:

      This study is designed to determine if different doses of buprenorphine (either tapering
      doses or steady doses) are effective in managing chronic, non-cancer pain in individuals who
      also are addicted to opiate pain medicines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of chronic refractory pain

          -  Clinical diagnosis of opiate dependency

        Exclusion Criteria:

          -  unable to pay for medication

          -  enrolled in a methadone maintenance program

          -  homelessness

          -  major mental illness

          -  pregnant women

          -  prisoners

          -  terminal cancer pain
Genicular Nerve Block for Total Knee Arthroplasty
Condition: Post-operative Pain
MeSH terms: Pain, Postoperative
Intervention: 15mL 0.25% bupivacaine; Genicular nerve block; Saline
Intervention description: Patients will be randomly assigned to either a genicular nerve block with bupivacaine or saline; The ultrasound-guided genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. Color Doppler will be used to identify the arterial structures which serve as landmarks for the corresponding nerves.
After skin local anesthetic infiltration, a 10 cm 21G insulated block needle will be inserted and aligned with the ultrasound scanning plane. Once satisfactory position of the needle is confirmed, 5mL of a solution containing 15 ml of 0.25% bupivacaine with 2mg dexamethasone or 5mL saline will be slowly injected. Spread of local anesthetic will be documented adjacent to the target nerve. This procedure will be performed at the site of the three genicular nerves described.; Patients will be randomly assigned to either a genicular nerve block with bupivacaine or saline
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Total knee replacement

Summary:

      This study seeks to examine the analgesic efficacy of genicular nerve blocks for pain after
      total knee replacement.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects scheduled for primary elective total knee arthroplasty

          -  American Society of Anesthesiologists Physical Status I-III

          -  BMI 18-40 kg/m2

        Exclusion Criteria:

          -  Inability to cooperate with protocol

          -  Inability to understand or speak English

          -  Allergy to ropivacaine, bupivacaine or other local anesthetic

          -  Contraindication to peripheral nerve block (e.g. local infection, neurologic deficit
             or disorder, previous trauma or surgery to ipsilateral knee, etc.)

          -  Revision knee surgery

          -  Chronic opioid consumption (daily morphine equivalent of >30 mg for at least four
             weeks prior to surgery)

          -  History of chronic pain

          -  History of psychiatric disorder

          -  History of diabetes mellitus
Countermeasures to Reduce Sensorimotor Impairment and Space Motion Sickness Resulting From Altered Gravity Levels
Condition: Vestibular
MeSH terms: Motion Sickness; Space Motion Sickness
Intervention: Promethazine; Hyper gravity training; Placebo; No hypergravity training
Intervention description: Subject receives promethazine; Subject receives hypergravity training before testing; Placebo; Subjects do not receive normal Earth gravity
Intervention MeSH terms: Promethazine; Diphenhydramine
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The design includes three separate studies:
Arm 9&10 follows a crossover design. These results were reported in Diaz-Artiles et al 2017.
Arms 1-4 are a separate study which follow a factorial design, with arm 2 serving as the placebo, arms 1 and 3 assessing the effects of two separate interventions and arm 4 assessing the effect of two combined interventions.
Arms 5-8 are a separate study which follow a factorial design, with arm 6 serving as the placebo, arms 5 and 7 assessing the effects of two separate interventions and arm 8 assessing the effect of two combined interventions.
Masking: Double (Participant, Investigator)
Masking description: Double masking applies to arms 9&10. Other arms use participant masking only.
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The investigators will study adaptation of motion perception and manual control in altered
      gravity, including the effects of a drug (promethazine). The investigators will also study
      whether promethazine affects motion perceptual thresholds.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be in general good health

        Exclusion Criteria:

          -  Anyone who is not generally in good general health does not qualify

          -  Cardiovascular disease

          -  Severe diabetes

          -  Respiratory condition (e.g. asthma or emphysema)

          -  Narrow angle glaucoma

          -  Prostatic hypertrophy

          -  Gastrointestinal disorders
Study Evaluating Etanercept in the Treatment of Subjects With Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Etanercept
Intervention MeSH terms: Etanercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 720.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriasis

Summary:

      This study will provide a direct comparison of 'continuous therapy' and 'intermittent
      therapy' with withdrawal and retreatment upon return of psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stable, active plaque psoriasis

          -  Failure to respond to the following systemic therapies: Methotrexate, Cyclosporine,
             PUVA or Fumarate

        Exclusion Criteria:

          -  Evidence of skin conditions other than psoriasis that would interfere with evaluations
             of the effect of the study

          -  Systemic psoriasis therapy within 28 days prior
Comparison of the Effect of Vytorin 10/80 Tablet Split Into 4 and Simvastatin 20 Milligrams on Low-density Lipoprotein (LDL) Cholesterol
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Vytorin; Simvastatin
Intervention description: Vytorin 10/80 split into 4; Simvastatin 20 milligrams
Intervention MeSH terms: Simvastatin; Ezetimibe, Simvastatin 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: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hypercholesterolemia; Statins; Ezetimibe

Summary:

      The purpose of this study is to compare the efficacy of a Vytorin 10/80 tablet, an approved
      agent for the treatment of elevated LDL cholesterol which combines the cholesterol absorption
      inhibitor Ezetimibe 10 mg and simvastatin 80 mg, when split into 4 using a tablet splitter,
      versus a whole simvastatin 20 milligram tablet.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with an LDL-cholesterol greater than 100 mg/dL

          -  Patients willing and able to provide signed informed consent

        Exclusion Criteria:

          -  Patients receiving a statin (Lipitor, Crestor, Lescol, Simvastatin, or Pravachol)

          -  Patients intolerant of statins

          -  Patients receiving ezetimibe

          -  Patients intolerant of ezetimibe

          -  Patients receiving a niacin preparation

          -  Stroke, TIA, myocardial infarction, unstable angina, percutaneous coronary
             intervention, coronary artery bypass surgery, or major surgery within 3 months

          -  Cancer undergoing active treatment

          -  Creatinine clearance < 50 ml/minute

          -  Active liver disease or persistent elevation of SGOT or SGPT > 2 times the upper limit
             of normal level

          -  Participation in any clinical study within the last 30 days

          -  Drug addition or alcohol abuse within the past 6 months

          -  Use of azole antifungal agents, amiodarone, fibrates or immunosuppressant drugs within
             the last 3 months

          -  Active use of macrolide antibiotics or verapamil

          -  Consumption of grapefruit juice on a daily basis

          -  Patients unwilling or unable to provide informed consent

          -  Patients with poor compliance

          -  Women of childbearing potential
An Open-Label, Prospective Study to Assess the Safety and Effectiveness of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in the Russian Federation
Condition: Moderate to Severe Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Adalimumab
Intervention MeSH terms: Adalimumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Moderate to Severe Plaque Psoriasis

Summary:

      This is an open-label study designed to establish the safety and effectiveness of adalimumab
      in the treatment of moderate to severe plaque psoriasis after 24 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

        A patient will be eligible for study participation if he/she meets the following criteria:

          1. Male and female patients ≥ 18 years of age.

          2. Clinical diagnosis of psoriasis for at least 6 months as determined by patient
             interview of his/her medical history and confirmation of diagnosis through physical
             examination by the investigator.

          3. Stable plaque psoriasis for at least 2 months before Screening and Baseline visits as
             determined by patient interview of his/her medical history.

          4. Moderate to severe plaque psoriasis defined by ≥ 10% Body Surface Area (BSA)
             involvement at the Baseline visit.

          5. PASI (Psoriasis Area and Severity Index) score ≥ 10 at the Baseline visit.

        Exclusion Criteria:

          1. Diagnosis of erythrodermic psoriasis, pustular psoriasis, medication induced or
             medication-exacerbated psoriasis or new onset of guttate psoriasis.

          2. Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or
             viral) that may interfere with evaluation of psoriasis.

          3. Patient who cannot discontinue topical therapies for the treatment of psoriasis such
             as corticosteroids, vitamin D analogs, or retinoids at least 14 days prior to the
             Baseline (Week 0) visit and during the study. Participants are allowed to use:

               -  Shampoos that contain no corticosteroid;

               -  Bland (without beta or alpha hydroxy acids or containing no psoriasis treatment)
                  emollients;

               -  Low potency topical corticosteroids on the palms, soles, face, inframammary area,
                  and groin only.

          4. Patient who cannot avoid UVB (Ultraviolet-B) phototherapy for at least 14 days prior
             to the Baseline (Week 0) visit and during the study.

          5. Patient who cannot avoid PUVA (psoralen + ultraviolet A) phototherapy for at least 28
             days prior to the Baseline (Week 0) visit and during the study.
Adult Study / OROS Methylphenidate Hydrochloride (HCL) (OROS MPH) in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: OROS MPH; Placebo; OROS MPH Tablets; Placebo Tablets
Intervention description: Optimal Patient Dose (18 mg-72 mg) once daily for 6 weeks; Optimal Patient Dose (placebo to match 18 mg - 72 mg) once daily for 6 weeks; Optimal Patient Dose (18 mg-72 mg) once daily by mouth for 6 weeks; Optimal Patient Dose (placebo to match 18 mg - 72 mg) once daily by mouth for 6 weeks
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 357.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Osmotic Release Oral System (OROS®) Extended Release Methylphenidate HCl; CONCERTA® (OROS MPH)

Summary:

      The purpose of this study is to compare the ADHD symptom response of adults with ADHD treated
      with OROS MPH to those treated with placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults

          -  ADHD diagnosis (any type: Combined, Predominantly Inattentive, or Predominantly
             Hyperactive-Impulsive)

          -  Patients with an Adult ADHD Investigator Symptom Rating Scale (AISRS) score greater
             than 24 at screening/baseline

          -  Ability to read and understand English

        Exclusion Criteria:

          -  Any significant history of cardiovascular disease or cardiovascular disease detectable
             via ECG

          -  History of diagnosis of substance or alcohol dependence or admission/hospitalization
             for rehabilitation for dependence

          -  Current neurologic or psychiatric diagnosis that would make patient inappropriate for
             participation

          -  Anxiety assessments of moderate or severe

          -  Depression assessments of moderate or severe

          -  History or current suicidal thoughts or attempts

          -  Known allergies, hypersensitivity, or intolerance to OROS MPH
Lundbeck TOMs Orthostatic Hypotension
Condition: Orthostatic Hypotension; Idiopathic Parkinson Disease
MeSH terms: Parkinson Disease; Hypotension, Orthostatic; Hypotension
Intervention: Droxidopa 100 MG [Northera]
Intervention description: droxidopa taken three times a day titrated up to a maximum of 600 mg.
Intervention MeSH terms: Droxidopa
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Orthostatic hypotension (OH), which consists in a significant reduction in blood pressure
      levels upon standing from a seated position, may affect approximately one in three patients
      with Parkinson's disease (PD). It usually presents as dizziness, lightheadedness, feeling
      faint, or feeling like you might black out while standing. This can significantly impact the
      quality of life (QoL) of PD patients, resulting in difficulties with balance, walking, and
      increased risk of falls. The main aim of this study is to evaluate whether the use of
      technological devices (a computerized system for analyzing abnormalities in walking in
      clinical settings and a wearable sensor to detect changes in postural unsteadiness in the
      home environment) may improve the detection of complications and the response to medical
      therapies for OH in patients with PD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of idiopathic Parkinson's Disease, meeting UK Brain Bank criteria for at
             least 3 years

          -  Hoehn and Yahr (H&Y) stage I-III

          -  Age between 30 and 80 years old (both inclusive)

          -  Stable dosage of dopaminergic medications for at least 4 weeks

          -  Orthostatic Hypotension, defined as a fall in systolic BP ≥ 20 mmHg or diastolic BP ≥
             10 mmHg within 3 minutes of standing

          -  Willingness and ability to comply with scheduled visits

        Exclusion Criteria:

          -  Diabetes mellitus or other diseases potentially associated with autonomic dysfunction

          -  Treatment with antihypertensive drugs or with alpha-adrenergic antagonists

          -  Cognitive impairment, defined as a score < 24 at the Montreal Cognitive Assessment
             (MoCA)

          -  Any atypical signs lowering the diagnostic certainty for PD

          -  Lack of postural reflex defined as a score > 2 at the MDS-UPDRS item 3.12 (recover at
             the pull test)

          -  Severe levodopa induced dyskinesia, defined as an MDS-UPDRS item 4.2 > 2 (functional
             impact of dyskinesia)
Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk
Condition: Atrial Fibrillation; Atrial Flutter; Stroke; Embolism, Systemic Arterial; Major Bleeding
MeSH terms: Stroke; Atrial Fibrillation; Embolism; Atrial Flutter
Intervention: Home Monitoring Guided OAC; Physician-Directed OAC
Intervention description: Active monitoring for atrial episodes through the automatic HM notifications (email, fax, short message service) is required. If the total duration over 48 consecutive hours reaches the predefined anticoagulation condition, and AF/AFL diagnosis is confirmed using the IEGM online, the site instructs the patient by telephone to start OAC. Clinicians continue to monitor patients using HM, and if freedom from AF/AFL reaches the predefined interval, stop of OAC therapy is requested over the telephone. Following stop of anticoagulation, any recurrence of AF/AFL requires restart of OAC therapy.
OAC drugs used: Dabigatran etexilate, Rivaroxaban, Warfarin, other approved VKA; Patients will receive physician-directed anticoagulation therapy based on conventional criteria.
OAC drugs used: Dabigatran etexilate, Rivaroxaban, Warfarin, other approved VKA
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 2718.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Implanted Cardioverter Defibrillator; Cardiac Resynchronization Therapy Defibrillator; Home Monitoring; Oral Anticoagulation

Summary:

      The IMPACT Study will investigate the potential clinical benefit of the combined use of
      BIOTRONIK Home Monitoring (HM) technology and a predefined anticoagulation plan compared to
      conventional device evaluation and physician-directed anticoagulation in patients with
      implanted dual-chamber defibrillators or cardiac resynchronization therapy devices.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Candidates for implantation of, or already implanted with, a BIOTRONIK Lumax HF-T or
             DR-T device

          -  Documented P wave mean amplitude ≥ 1.0 mV (sinus rhythm) or ≥ 0.5 mV (AF) at
             enrollment, if previously implanted

          -  CHADS2 risk score ≥ 1

          -  Able and willing to follow OAC therapy if the indication develops during the course of
             the trial

          -  Able to utilize the HM throughout the study

        Key Exclusion Criteria:

          -  Permanent AF

          -  History of stroke, transient ischemic attack (TIA) or systemic embolism and documented
             AF or AFL

          -  Currently requiring OAC therapy for any indication

          -  Patients who underwent successful AF ablation (sinus rhythm restored) and have not
             completed a minimum of 3 months of OAC therapy

          -  Known, current contraindication to use of eligible OAC

          -  Long QT or Brugada syndrome as the sole indication for device implantation

          -  Life expectancy less than the expected term of the study
Management of Sub-Clinical Bacteriuria in Pregnancy
Condition: Cystitis; Cystitis;Puerperium; Pyelonephritis
MeSH terms: Bacteriuria; Cystitis; Pyelonephritis
Intervention: Antibiotic; Standard Prenatal Care
Intervention description: Those randomized for treatment will be prescribed the most commonly used antibiotic for urinary tract infections in pregnancy. This includes: Nitrofurantoin, Cephalexin, and Amoxicillin. It is unsure which antibiotic the participant will receive but a majority of the time it will be one of the above named antibiotic. The choice will be determined by the physician, but will accommodate participants' prior medication history and adverse events.; Continued surveillance of urinary cultures
Intervention MeSH terms: Anti-Bacterial Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to determine if treatment of pregnant women with urine cultures
      with a low level of bacteria (less than 100,000 colony forming units (CFU)) may decrease
      adverse pregnancy outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant women who seek prenatal care within the University of Texas Health System
             with UT Physicians.

          -  Urine culture of less than 100,000 CFU

        Exclusion Criteria:

          -  Less than 18 years of age

          -  Risk factors to complicated UTI (including but not limited to: diverticula,
             urolithiasis, renal cysts, indwelling catheter, intermittent catheterization, stent
             placements, nephrostomy tubes, neurogenic bladder, cystocele, vesicoureteral reflux,
             ileal conduit)

          -  Use of immunosuppressant drugs

          -  Abnormalities of the urinary tract (including but not limited to: known ureteric or
             urethral strictures, tumors of the urinary tract, pelvicalyceal obstruction,
             congenital anomalies, history of urological procedures)

          -  History of renal disease including renal failure and transplants

          -  Urine culture > 100,000 CFU of any organism