bioihbjkbjnl/mcl2 huggingface dataset:
Study to Assess Changes in the Immune Profile in Adults With Early Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Abatacept; Adalimumab; Methotrexate
Intervention MeSH terms: Adalimumab; Methotrexate; Abatacept
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to examine changes in immune cells and proteins in response to
      treatment with two approved therapies for Rheumatoid arthritis (RA), abatacept versus
      adalimumab, both given in combination with methotrexate.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Symptoms of RA for no more than 12 months prior to enrollment

          -  Meet American College of Rheumatology/European League against Rheumatism (ACR/EULAR)
             2010 criteria for classification of RA

          -  Treated with Methotrexate (MTX) for at least 12 weeks prior to randomization with a
             stable oral dose for at least 4 weeks, Subjects must randomize on the maximum
             tolerated dose of oral methotrexate (minimum of 15 mg and maximum of 25 mg per week),
             dose of MTX < 15 mg/week but ≥ 7.5 mg/week is permitted if subjects are intolerant to
             higher doses

          -  At least 3 tender & 3 swollen joints

          -  Anti-cyclic citrullinated peptide (CCP) > 3X the upper limit of normal and positive
             rheumatoid factor

        Exclusion Criteria:

          -  History of other autoimmune diseases (eg, psoriasis, systemic lupus, erythematosus,
             etc)

          -  Prior use of non-biologic therapy other than methotrexate

          -  Prior use of biologic and targeted synthetic disease-modifying anti-rheumatic drugs
             (DMARD) therapy

          -  Subjects with chronic or recent acute serious infection

        Other protocol defined inclusion/exclusion criteria could apply
Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: Teriparatide; Denosumab
Intervention description: teriparatide daily subcutaneous injection; denosumab subcutaneous injection
Intervention MeSH terms: Denosumab; Teriparatide
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 37.0
Sex: Female
Minimum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: osteoporosis; histomorphometry; bone density; teriparatide; denosumab

Summary:

      The purpose of this study is to examine, via iliac crest bone biopsies, the mechanism of
      combined teriparatide and denosumab on the bone of postmenopausal osteoporotic women after 3
      months of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  women aged 45+

          -  postmenopausal

          -  osteoporotic with high risk of fracture

        Exclusion Criteria:

          -  significant previous use of bone health modifying treatments

          -  known congenital or acquired bone disease other than osteoporosis

          -  significant renal disease, liver disease, cardiopulmonary disease, or psychiatric
             disease

          -  abnormal calcium or parathyroid hormone level

          -  serum vitamin D <20 ng/mL or >60ng/mL

          -  serum alkaline phosphatase above upper normal limit with no explanation

          -  anemia (hematocrit <32%)

          -  history of malignancy (except non-melanoma skin carcinoma), radiation therapy, or
             gouty arthritis

          -  history of urolithiasis within the last one year

          -  excessive alcohol use or substance abuse

          -  use of oral or parenteral glucocorticoids for more than 14 days within the past 6
             months

          -  extensive dental work involving extraction or dental implant within the past or
             upcoming 2 months

          -  known sensitivity to mammalian cell-derived drug products

          -  known contraindications to denosumab, teriparatide, or any of their excipients

          -  known contraindications to tetracycline, demeclocycline, or other antibiotics in this
             drug class

          -  continuous use of tetracycline for >1-month duration within the last 10 years
Ketamine for Acute Pain Management After Trauma
Condition: Trauma Injury; Pain; Opioid Use
MeSH terms: Acute Pain; Wounds and Injuries
Intervention: Ketamine plus usual care; Usual Care
Intervention description: Bolus of .35 mg/kg Infusion start @ 0.15 mg/kg/hr; titrate range is 0.1 - 0.25 mg/kg/hr for 24 to 48 hours after admission and each subsequent major surgery plus multi-modal pain therapy considered as standard of care. Standard of care medications include Acetaminophen 1000 mg po q6 hours, Naproxen 500 mg po q12 hours, Gabapentin 300 mg po q8 hours and Lidocaine patch q 12 hours.; Standard of care medications include Acetaminophen 1000 mg po q6 hours, Naproxen 500 mg po q12 hours, Gabapentin 300 mg po q8 hours and Lidocaine patch q 12 hours.
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 305.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Multimodal Pain Therapy; Ketamine; Trauma

Summary:

      The purpose of this study is to compare the effectiveness of Ketamine drip along with usual
      care and usual care alone on trauma patients and to longitudinally quantify the pain
      experience of patients during hospitalization.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult trauma patients

          -  Admission to Shock Trauma ICU (STICU) or Surgical Intermediate Unit (SIMU)

          -  Randomization within 6 hours of arrival

        Exclusion Criteria:

          -  Patient not expected to survive

          -  Contraindications to ketamine Allergy, Poorly controlled hypertension, Cardiac
             arrhythmia disorders (including atrial fibrillation), congestive heart failure,
             unstable coronary artery disease or recent myocardial infarction( MI)(within 6
             months), cirrhosis, seizure disorder, and for those patients with unknown medical
             history - median sternotomy scar, mechanism of injury is fall from standing, 65 years
             of age or older, any arrhythmia on EKD)

          -  pregnancy

          -  in police custody

          -  history of dementia or movement disorder (i.e. Parkinson's)
Oral Sedation During Cervical Dilator Placement
Condition: Oral Sedation and Cervical Dilator Pain
Intervention: Oxycodone and Lorazepam (Active Comparator); Placebo Comparator
Intervention description: Oxycodone and Lorazepam; Placebo oral pills
Intervention MeSH terms: Oxycodone; Lorazepam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The participant, provider, and nursing staff will be blinded to the intervention. The pharmacy will prepare the treatment drugs and placebos.. Randomization will be stratified by gestational age (>= 20 weeks or <20 weeks) and the randomization allocation sequence will be computer-generated with a random number generator by a statistician. The pharmacist will be aware of the randomization sequence and will dispense the drugs as appropriate, while keeping track of which arms participants were randomized to.
Enrollment: 27.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Oral Sedation; Lorazepam; Oxycodone

Summary:

      This will be a randomized, double-blind, placebo-controlled trial involving 2 arms. It will
      be comparing the effects of placebo compared to 1 mg oral lorazepam/5 mg oral oxycodone on
      pain scores during cervical dilator placement prior to dilation and evacuation (D&E).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women aged 18-50 years

          -  English speaking

          -  With an intrauterine pregnancy (either viable or non-viable) between the gestational
             ages of 17w0d and 23w6d

          -  Have a support person present with participant

          -  Have a cell phone capable of text messaging (optional)

        Exclusion Criteria:

          -  Non-English-speaking

          -  Taking a daily benzodiazepine or opiate

          -  Have a known allergy or contraindication to NSAIDs, opiates, or benzodiazepines
Smoking Cessation Treatment for Methadone Maintenance Patients
Condition: Smoking Cessation; Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Intervention: Varenicline; Placebo
Intervention description: Days 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day; Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily
Intervention MeSH terms: Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: methadone maintenance

Summary:

      Patients in substance abuse treatment smoke four times more than non-substance abusers, and
      suffer high rates of tobacco-related disease and death. While many quit smoking treatments
      exist that have been shown to help non-substance abusers quit smoking, little is known about
      what treatments work for patients in substance abuse treatment. The drug varenicline
      (Chantix) has been shown to be more effective at helping people quit smoking than nicotine
      replacement therapy, bupropion or placebo. However, varenicline has not yet been studied in
      patients in substance abuse treatment. The study aims to evaluate the feasibility,
      effectiveness and safety of varenicline, in combination with counseling, in methadone
      maintained smokers. It also aims to evaluate the link between quitting smoking and alcohol
      and illicit drug use in methadone maintained smokers. We hypothesize that participants
      receiving varenicline will have higher abstinence from smoking than participants receiving
      placebo and that participants taking varenicline will not have significantly more adverse
      reactions than were described in the general population in other studies. We also hypothesize
      that compared to continued smokers, tobacco abstainers will be more likely to be abstinent
      from alcohol or illicit drugs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 or older

          -  English speaking

          -  Smoked at least 100 cigarettes/lifetime

          -  Smokes 5 or more cigarettes per day

          -  Interested in quitting smoking (preparation or contemplation state of change)

          -  Enrolled in Einstein/Montefiore methadone program for 3 or more months

          -  Stable methadone dose for 2 weeks

          -  Agree to use contraception throughout the trial (among women with reproductive
             potential)

          -  Willing to participate in all study components

          -  Able to provide informed consent

        Exclusion Criteria:

          -  Serious or unstable HIV/AIDS, liver, cardiovascular, or pulmonary disease

          -  Psychiatric instability

          -  Women who are pregnant, breastfeeding, or contemplating pregnancy

          -  Creatinine clearance less than 30 mL/min
Sildenafil in Heart Failure With Reactive Pulmonary Hypertension
Condition: Heart Failure With Reactive Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension; Heart Failure
Intervention: Sildenafil; Placebo
Intervention description: 20 mg three times daily by mouth for 90 days; One capsule three times daily by mouth for 90 days
Intervention MeSH terms: Sildenafil Citrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether Sildenafil 20mg taken three times a day is
      effective in the treatment of Heart Failure with Reactive Pulmonary Hypertension. This is a
      double-blind, placebo controlled trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Known chronic heart failure appropriately treated with Angiotensin converting enzyme
             (ACE) inhibitors and beta blockers, unless contraindicated or poorly tolerated

          -  indication for right heart catheterization

          -  pulmonary artery mean pressure >25 mmHg

          -  pulmonary capillary wedge pressure > 15 mmHg

          -  pulmonary vascular resistance > 3 Wood units

        Exclusion Criteria:

          -  hypersensitivity, allergy, or intolerable side effect to sildenafil

          -  history of primary pulmonary hypertension, connective tissue disorder, severe chronic
             obstructive pulmonary disorder (COPD), pulmonary embolism, or left to right shunt

          -  co-morbidities, limited exercise intolerance:

               -  morbid obesity (BMI >40)

               -  COPD with oxygen dependence

               -  severe peripheral vascular disease with intermittent claudication

               -  status post amputation of lower extremity at any level

               -  severe degenerative joint disease preventing normal walking
Study to Assess Impact of Dysport Injections Early After Stroke on Upper Limb Spasticity Progression
Condition: Stroke; Upper Limb Spasticity
MeSH terms: Muscle Spasticity; Stroke
Intervention: Botulinum toxin type A; Placebo
Intervention description: Subjects to receive Dysport® 500U administered intramuscularly in the targeted upper limb.; Placebo administered intramuscularly in the targeted upper limb.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
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: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate if early administration (i.e. within 12 weeks
      after stroke) of Dysport® 500 U injections may delay the appearance or the progression of
      upper limb symptomatic spasticity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  2 to 12 weeks after first ever stroke according to the World Health Organisation
             criteria (previous transient ischaemic attack or clinically silent infarct on
             computerised tomography (CT)/magnetic resonance imaging (MRI) are not counted as
             previous stroke)

          -  Stroke confirmed by CT/MRI scan and classified as ischaemic/haemorrhagic stroke

          -  Presence of spasticity:

               -  either symptomatic, based on symptomatic spasticity criteria (i.e. at least one
                  of the following items: impacted passive/active function, involuntary movements,
                  or pain ≥4 on a numeric pain rating scale [NPRS]), in addition to increased
                  muscle tone [Modified Ashworth Scale, MAS ≥2])

               -  or only increased muscle tone (MAS≥2)

        Exclusion Criteria:

          -  Neuromuscular junction (NMJ) diseases, or any other neurological disorders (including
             prior local joint, tendon, and intrinsic muscle disorders) that could potentially
             interfere with assessment of spasticity in the primary targeted muscle group selected
             by the Investigator and in agreement with the subject

          -  Currently receiving drugs affecting NMJ transmission e.g. aminoglycosides,
             aminoquinolines, cyclosporine, D penicillamine

          -  Previous surgery of the affected muscles/ ligaments/tendons

          -  Severe comorbidities (e.g. congestive heart failure, myocardial infarction, multiple
             organ failure, hepatic renal failures, severe infections)
Safety and Pharmacokinetic Study of ALO-02 in Children Ages 7-17 With Pain
Condition: Moderate-severe Pain
Intervention: ALO-02
Intervention description: Oral/Capsule, twice per day dosing; Treatment duration consists of a 1 to 4 week Conversion/Titration Phase leading to a 2 to 4 week Maintenance Treatment duration.
Intervention MeSH terms: Naltrexone; Oxycodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 7 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Pediatric; pain indication; controlled release oxycodone

Summary:

      Safety and pharmacokinetics of an abuse-deterrent, extended-release formulation of oxycodone
      hydrochloride with a sequestered naltrexone core in children 7-17 with moderate-severe pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children 7-17 with moderate to severe pain requiring around the clock treatment with
             an opioid analgesic.

          -  Be an experienced opioid user, defined as any subject treated with opioid therapy,
             equivalent or equal to > 6 mg per day of oxycodone, for a period of 3 consecutive days
             immediately prior to first day of dosing.

        Exclusion Criteria:

          -  Columbia-Suicide Severity Rating Scale (C-SSRS) for suicidal ideation and behavior in
             past year.

          -  Hypersensitivity to morphine, naltrexone.

          -  A life expectancy (assessed by investigator) of less than 6 months or is no longer
             capable of taking medication orally.

          -  Undergone surgery within 3 days prior to the first day of dosing.
Intrafetal Digoxin as an Adjuvant for Dilation and Evacuation at 20 to 24 Weeks' Gestation
Condition: Abortion
MeSH terms: Dilatation, Pathologic
Intervention: Digoxin; Placebo
Intervention description: Trans-abdominal injection; Trans-abdominal injection
Intervention MeSH terms: Digoxin
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 178.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a research study to measure the effect of digoxin injection on Dilation and
      Evacuation (D&E) procedure duration. Digoxin is the most commonly used feticidal agent among
      family planning subspecialists, and is commonly used for a variety of reasons including
      provider preference, patient preference, and concerns over legal status of later D&E
      procedures. There have been several studies on digoxin administration, adverse effects, and
      impact on the D&E procedure, but doctors want to clarify how digoxin effects D&E procedure
      time, if at all.
    

Eligibility criteria:

        Inclusion Criteria:

          -  20 weeks 0 days-24 weeks 0 days gestation

          -  English or Spanish speaking

          -  18 years or older

        Exclusion Criteria:

          -  Under 18

          -  Contraindications to digoxin
Coronavirus Induced Acute Kidney Injury: Prevention Using Urine Alkalinization
Condition: COVID; Coronavirus; Coronavirus Infection; AKI; Acute Kidney Injury
MeSH terms: Coronavirus Infections; Acute Kidney Injury; Wounds and Injuries
Intervention: Sodium bicarbonate; Standard of Care
Intervention description: Sodium bicarbonate 225 mEq (225 mL of an 8.4% solution) intravenously over 1 hour. Sodium bicarbonate 8.4% solution should not exceed 900 ml (4 boluses) in 24 hours.; Standard of Care treatment
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group 1 (control) will receive standard of care treatment for coronavirus according to institutional protocols.
Group 2 (treatment) will receive sodium bicarbonate 225 mEq (225 mL of an 8.4% solution) intravenously over 1 hour.
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute Kidney Injury; AKI; COVID-19; Coronavirus; Sodium Bicarbonate

Summary:

      Our overarching goal is to improve the outcomes of critically ill COVID-19 patients with or
      at risk for development of acute kidney injury (AKI). The objective of this study is to
      determine the role of a protocol to manage urine alkalization using a simple medication that
      has been used for a very long time, is safe, and without significant side-effects. We aim to
      determine the feasibility and safety of a urine alkalinization protocol for the prevention of
      AKI in patients testing positive for COVID-19.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed COVID-19 positive

          -  Admission to ICU or step-down unit

          -  Age ≥ 18 years old

        Exclusion Criteria:

          -  Stage 3 AKI by KDIGO criteria

          -  CKD stage 4-5

          -  Contraindications to Na bicarbonate therapy (e.g. met. alkalosis, severe heart
             failure)

          -  Urine pH > 7.0