bioihbjkbjnl/mcl2 huggingface dataset:
Musculoskeletal Ultrasound Assessment of Therapeutic Response of Tofacitinib in Rheumatoid Arthritis Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: tofacitinib 5mg po bid
Intervention MeSH terms: Tofacitinib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; Musculoskeletal Ultrasound; Tofacitinib; biomarker

Summary:

      This proposal will evaluate if musculoskeletal ultrasound (MSUS) measures or multi-biomarker
      disease activity (MBDA) improve in patients treated with tofacitinib over 3 months, and
      whether early MSUS measures/MBDA can predict response to therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient must meet 1987 ACR criteria

          2. Age > 18 years of age

          3. Baseline DAS28/ESR>=3.2

          4. Stable concomitant DMARDs

          5. Stable prednisone <10mg or equivalent

          6. Power Doppler score of >=10

          7. Female subjects of childbearing potential must test negative for pregnancy

          8. Male and female subjects of childbearing potential must agree to use contraception
             throughout the study

          9. Negative QuantiFERON Gold test at screening

        Exclusion Criteria:

          1. No active TB

          2. Prednisone >10 mg

          3. Pregnancy or breast feeding

          4. Prior treatment with tofacitinib

          5. Concomitant biologic therapy (TNF inhibitors, IL-6 inhibitors, etc.)

          6. Active infection with HIV, hepatitis B or C, or herpes zoster

          7. Subjects with any uncontrolled clinically significant laboratory abnormality or any of
             the following laboratory abnormalities:

               1. Evidence of hematopoietic disorder or hemoglobin <9 g/dL

               2. Absolute lymphocyte count <0.75 x 109/L (<750/mm3)

               3. Absolute neutrophil count <1.2 x 109/L (<1200/mm3)

               4. Platelet count <100 x 109/L (<100,000/mm3)

               5. Alanine aminotransferase (ALT), or aspartate aminotransferase (AST) >1.5 times
                  the upper limit of normal (x ULN)

               6. Estimated GFR <40 ml/min

          8. Subjects who have received live or live attenuated vaccines within 6 weeks prior to
             the first dose of study drug (or the zoster vaccine)

          9. Subjects who require concomitant treatment with medications that are potent inhibitors
             of cytochrome P450 3A4 (CYP3A4), both moderate inhibitors of CYP3A4 and potent
             inhibitors of CYP2C19, and potent CYP inducers (See Appendix)
Comparison of Low-dose and High-dose Oxytocin Regimens for Labor Augmentation
Condition: Dystocia
MeSH terms: Dystocia
Intervention: Oxytocin; Sodium Chloride 0.9%
Intervention MeSH terms: Oxytocin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1003.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      Oxytocin is a medication that is often used to strengthen contractions to overcome delayed
      labor progress. The primary aim of this study is to determine whether receiving a higher dose
      of oxytocin lowers the chance of needing a cesarean section when compared to a lower dose of
      oxytocin. Other aims include examining the relationship between dose of oxytocin regimen and
      length of labor, postpartum hemorrhage, intrauterine infection, umbilical cord gas, neonatal
      Apgar score <5 at 5 minutes, and need for neonatal intensive care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to give informed written consent

          -  Age 18-45 years

          -  Nulliparous

          -  Pregnant with a live singleton gestation that is equal to or greater than 36 weeks

          -  Diagnosed with at least 6 regular uterine contractions in an observation period of no
             more than 60 minutes and at least one of the following: spontaneous rupture of
             membranes, OR cervix greater than or equal to 3 centimeters dilated OR cervix at least
             80% effaced.

          -  The participant's attending obstetric physician or midwife has determined that the
             participant needs administration of oxytocin infusion for labor augmentation. Labor
             augmentation will be defined as stimulation of uterine contractions when spontaneous
             contractions have failed to result in progressive cervical dilation of descent of
             fetus.

        Exclusion Criteria:

          -  Women not meeting the above criteria

          -  History of prior cesarean section or uterine surgery

          -  Fetus in non-cephalic presentation

          -  Participant is undergoing labor induction (i.e. cervical ripening)

          -  Non-English speaking
The SIM-SOF Trial for Hepatitis C
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Pegylated Interferon alfa-2b; Simeprevir; Ribavirin; Sofosbuvir
Intervention description: 1.5 ugm/kg/week subcutaneously injected along with ribavirin and sofosbuvir for 12 weeks total; 150 mg daily orally along with pegylated interferon and sofosbuvir for a total of 12 weeks; 1000-1200 mg daily divided twice daily for 12 weeks in combination with pegylated interferon and sofosbuvir; 12 weeks of combination sofosbuvir and simeprevir
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Sofosbuvir; Peginterferon alfa-2b; Simeprevir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cirrhosis

Summary:

      Randomized trial of Hepatitis C-genotype 1-infected patients with compensated cirrhosis
      comparing the standard of care (Peginterferon/Ribavirin/Sofosbuvir) versus the off-label
      combination of simeprevir+ sofosbuvir without Ribavirin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  chronic hepatitis c,

          -  cirrhosis biopsy-proven, or via fibrotest,

          -  CPT score less than 7,

          -  genotype 1a,

          -  INR 2.3 or less,

          -  serum albumin greater than 2.7 gm/dL,

          -  total bilirubin less than 3 gm/dL,

          -  platelet count 50,000 per cubic milliliter or more

          -  GFR >50 ml/min

        Exclusion Criteria:

          -  non genotype 1a,

          -  history of CPT class B or C or decompensation or history of same,

          -  HIV or HBV coinfection,

          -  prior treatment with boceprevir, telaprevir or any other direct acting antiviral
             agent,

          -  uncontrolled psychiatric or cardiopulmonary disorders,

          -  planning pregnancy or unwilling/unable to practice contraception
Efficacy of Haloperidol vs. Metoclopramide for Treatment of Acute Headaches and Migraines in the Emergency Department
Condition: Headache, Migraine
MeSH terms: Migraine Disorders; Emergencies; Headache
Intervention: Metoclopramide; Haloperidol; Normal Saline; Diphenhydramine
Intervention description: Patients receive 10 mg of intravenous (IV) metoclopramide.; Patients receive 2.5 mg of IV haloperidol.; All patients receive a 1-liter bolus of normal saline (NS); All patients receive 25 mg of intravenous (IV) diphenhydramine.
Intervention MeSH terms: Diphenhydramine; Promethazine; Haloperidol; Metoclopramide; Haloperidol decanoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metoclopramide (Reglan); Haloperidol (Haldol)

Summary:

      Metoclopramide (Reglan) is a common agent used for relief of headaches in the emergency
      department (ED).In this study the investigators seek to explore another option for treatment
      of headaches in the ED, one that may be more efficacious and efficient. Haloperidol (Haldol),
      a butyrophenone class of medication, is thought to act by affecting the dopamine 2 receptor
      in the brain.

      By exploring haloperidol as an option for treatment, the investigators hope to discover a
      more efficient and effective medication for the treatment of non-traumatic headaches, thereby
      decreasing a patient's length of stay in the department and decreasing the rate of return
      visits for continued discomfort from the same headache. This study could lead to the
      increased usage of haloperidol as a first line agent in the treatment of prolonged headaches
      presenting to the ED.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who present with a headache or migraine with onset less than or equal to 72
             hours

        Exclusion Criteria:

          -  Known pregnancy

          -  Breast-feeding women

          -  Known history of arrhythmias or QT prolongation (450 ms)

          -  Known adverse effects to haloperidol, diphenhydramine (Benadryl) or metoclopramide

          -  Subarachnoid hemorrhage

          -  Headaches caused by trauma, meningitis

          -  Congestive heart failure

          -  Parkinson's Disease

          -  Dementia

          -  Pheochromocytoma

          -  History of glaucoma

          -  History of seizures

          -  Non-English speaking patients
The Efficacy and Safety of Low Dose Combination of LTG and VPA Compared to CBZ Monotherapy
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Carbamazepine; Lamotrigine/Valproate
Intervention MeSH terms: Lamotrigine; Carbamazepine; Valproic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 207.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy of usual monotherapy and low dose combination of Lamotrigine and
      Valproate. Low dose combination may be more effective and tolerable because they are low dose
      and VPA reduce Lamotrigine metabolism.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥16yr old

          -  Who are diagnosed as epilepsy definitely

          -  Who have minimum 2 unprovoked seizures and minimum 1 seizure in previous 3 months

          -  Who need AED therapy and no AED medication for previous 1 year (exclude emergency
             medication for less than 2weeks)

          -  Who is not pregnant

          -  Who can report seizure diary by him/herself or caregiver

          -  Who agree to this trial and provide informed consent.

          -  Type of seizures : of generalized tonic-clonic, complex partial, and/or simple partial
             motor seizures;

        Exclusion Criteria:

          -  Who has progressive CNS disease.

          -  Has serious systemic or psychiatric disease

          -  Who is not suitable by investigator(uncooperative)

          -  Who can not fill up diary check card

          -  Is pregnant, breastfeeding, or planning to become pregnant

          -  Exclusion - absence s. juvenile myoclonic epilepsy, atonic seizure, alcohol or other
             substance abusers, mental retardation etc.

          -  Who cancels to agree to this trial and provide informed consent.

          -  ALT, AST, bilirubin and BUN/Cr levels are more than twice normal range of them

          -  WBC value is 2000 and less, Hb value is 9.0 and less, platelet count is 100,000 and
             less in CBC

          -  Who took investigation products before participating this study
Tacrolimus Versus Prednisolone for the Treatment of Minimal Change Disease
Condition: Minimal Change Disease
MeSH terms: Nephrosis, Lipoid
Intervention: tacrolimus; prednisolone
Intervention description: tacrolimus0.05mg/kg bd (levels 6-12ng/ml); Prednisolone 1mg/kg maximum 60mg od
Intervention MeSH terms: Prednisolone; Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: nephrotic minimal change tacrolimus prednisolone

Summary:

      The purpose of this study is to compare the effectiveness of tacrolimus (prograf) versus
      prednisolone for the treatment of nephrotic syndrome secondary to minimal change disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with nephrotic syndrome (hypoalbuminaemia and protein creatinine ratio (PCR)
             > 100units), secondary to minimal change disease.

          -  Age over 18.

        Exclusion Criteria:

          -  Hepatitis B, hepatitis C or HIV infection.

          -  Untreated infection.

          -  Females who are pregnant, breast feeding, or at risk of pregnancy and not using a
             medically acceptable form of contraception.

          -  Patients who have been treated with immunosuppression over the last 18 months.

          -  Patients who have had more than 3 relapses of nephrotic syndrome within 5 years.

          -  Any condition judged by the investigator that would cause the study to be detrimental
             to the patient.
Acetaminophen's Efficacy For Post-operative Pain
Condition: Tonsillitis; Airway Obstruction; Difficulty Swallowing
MeSH terms: Tonsillitis; Deglutition Disorders; Airway Obstruction
Intervention: IV acetaminophen; PO acetaminophen
Intervention description: IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR .; PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30minutes) prior to induction of anesthesia in the pre-operative area.
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 41.0
Sex: All
Minimum age: 5 Years
Maximum age: 13 Years
Healthy volunteers: No
Keywords: tonsillitis; recurrent tonsillitis; obstructed air passages; swallowing difficulties

Summary:

      The purpose of this study is to compare IV acetaminophen to oral acetaminophen for pain
      control in children undergoing tonsillectomy with or without adenoidectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children 5-13 years of age

          -  Surgical procedure: tonsillectomy with or without adenoidectomy

          -  American Society of Anesthesiologists physical status classification 1 and 2 (patients
             that have either no systemic illness or mild systemic disease that is well-controlled,
             e.g. mild asthma)

        Exclusion Criteria:

          -  Known allergy to study medication(s)

          -  Known genetic abnormality

          -  Known hepatitis

          -  Children with other physical, mental or medical conditions which, in the opinion of
             the PI, make study participation inadvisable or impairs pain assessment

          -  Children who have taken any analgesic within 24 hours prior to surgery

          -  Enrollment in concurrent research study

          -  Pregnant patients*

          -  Students/trainees/staff*

          -  Mentally disabled/cognitively impaired*
Low Level Laser Treatment and Breast Cancer Related Lymphedema
Condition: Lymphedema
MeSH terms: Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema
Intervention: laser and MLD combined; laser alone; manual lymphatic drainage
Intervention description: The intervention is therapist administered laser and mld treatment combined; The intervention is therapist administered laser; The intervention is therapist administered manual lymphatic drainage
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: Female
Minimum age: 21 Years
Healthy volunteers: No
Keywords: lymphedema; quality of life; breast cancer; symptoms; lymphedema in breast cancer survivors

Summary:

      Manual Lymphatic Drainage (massage therapy) with compression (wearing a tight sleeve on the
      arm) is the current standard of treatment for breast cancer related lymphedema (arm
      swelling). Low-Level Laser Therapy (LLLT) was approved in 2006 by the FDA for professional
      and self/home treatment of lymphedema. LLLT is being offered as a treatment option in many
      lymphedema treatment settings, but there are few studies of the effectiveness of LLLT as a
      stand-alone lymphedema treatment or as a possible complementary lymphedema treatment modality
      to Manual Lymphatic Drainage. The objective of this proposed pilot study is to examine the
      impact of Advance Practice Nurse (ANP) administered LLLT, as both a stand-alone and
      complementary treatment, on arm volume, symptoms, and quality of life (QOL) in breast cancer
      survivors with lymphedema. Findings from this pilot study will be used to determine if LLLT
      has possible value in the treatment of lymphedema and warrants subsequent evaluation in a
      larger study.
    

Eligibility criteria:

        Inclusion Criteria:

        Breast cancer survivors will be included if they:

          1. are age 21 or older;

          2. require professional treatment for Stage I or II lymphedema as defined by the
             International Society of Lymphology;

          3. have an order for lymphedema treatment; and

          4. are willing and able to drive to the study sites.

        Exclusion Criteria:

        Individuals will not be included if they:

          1. are actively undergoing intravenous chemotherapy or radiation therapy;

          2. have a history of bilateral lymphedema that prohibits extracellular fluid comparison
             to an unaffected limb;

          3. are unable to stand upright for measurement of height and weight;

          4. have active/metastatic cancer;

          5. are pregnant,:

          6. have artificial joints in areas where electrode placement is critical, or have a
             pacemaker/internal defibrillator; or

          7. have congestive heart failure (CHF), chronic/acute renal or hepatic disease, pulmonary
             edema, thrombophlebitis, deep vein thrombosis (DVT), acute infection of any kind, and
             inflammation in the trunk or arms.
Bowel Preparation for Colonoscopy in Children
Condition: Colonoscopy Preparation
Intervention: polyethylene glycol, senna
Intervention description: Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.
Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days.
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 33.0
Sex: All
Minimum age: 6 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Preparation; Pediatric; Colonoscopy

Summary:

      The primary objective of this study is to determine whether Miralax results in a more
      efficacious preparation as compared to senna for pediatric colonoscopy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects age 6-21 yrs for senna, PEG-P groups

          2. Subjects age 13-21 yrs for NaP group

          3. First time colonoscopy

          4. Patient weight <70 kg for PEG-P group (to not exceed 51 grams/dose)

        Exclusion Criteria:

          1. Chronic renal, liver, or heart failure

          2. Chronic constipation

          3. Patients on the GI inpatient or consult service.

          4. Subjects taking senna or PEG on a regular basis for laxative reasons.

          5. Pregnant or lactating females
Adult Oral Ibuprofen Study for ED Pain Patients
Condition: Pain, Acute
MeSH terms: Acute Pain
Intervention: Oral Ibuprofen
Intervention description: Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg
Intervention MeSH terms: Ibuprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 225.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: Emergency Medicine; Acute Pain; Oral Ibuprofen

Summary:

      Ibuprofen is one of the most widely used non-steroidal anti-inflammatory drug (NSAID) for
      management of mild -to moderate pain in the ED (acute musculo-skeletal pain, headache, dental
      pain). Ibuprofen as a representative of NSAID's as a class follows the analgesic ceiling
      concept that postulates that there is a dose of a drug beyond which any further dosage
      increase results in no additional analgesic effect. Despite this fact, Ibuprofen may commonly
      be used at doses above its analgesic ceiling, although this may not offer an incremental
      analgesic advantage and potentially adds risk of harm. The analgesic ceiling dose for
      ibuprofen is only 200-400mg/dose, and about 1200 mg/day. Thus, we hypothesize that
      administration of Ibuprofen in a dose of 400 mg in the ED is as effective in treating
      mild-to-moderate acute pain in patients presenting to the ED as 600 mg and 800 mg
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult ED patients aged 18 and older

          -  Chief complaint of mild to moderate musculoskeletal pain, headache, or dental pain
             intensity of less than 4 on a standard 0 to 10 numeric rating scale.

          -  Acute pain (within 30 days of onset)

          -  Patients who would routinely be treated with oral ibuprofen

        Exclusion Criteria:

          -  pregnancy or breastfeeding,

          -  active peptic ulcer disease,

          -  acute gastrointestinal hemorrhage,

          -  known history of severe renal or hepatic insufficiency, allergy to nonsteroidal
             anti-inflammatory drugs,

          -  patients having already received analgesic medication.