bioihbjkbjnl/mcl2 huggingface dataset:
Long Term Study of Avonex Therapy Following a First Attack of Multiple Sclerosis
Condition: Multiple Sclerosis; Optic Neuritis; Transverse Myelitis; Acute Brainstem/Cerebellar Syndrome
MeSH terms: Myelitis; Myelitis, Transverse; Multiple Sclerosis; Neuritis; Optic Neuritis; Cerebellar Diseases; Sclerosis
Intervention: interferon beta 1a 30 ug IM once weekly
Intervention description: Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date.
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking description: Open label study: The outcome committee determined the primary outcome event (the development of Clinically definite MS) without knowledge of original treatment assignment and the central MRI reading center was not aware of original treatment assignments
Enrollment: 155.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple sclerosis; Interferon Beta; MRI; Optic neuritis; Transverse Myelitis

Summary:

      The current study is a continuation of the 5 year extension study of the phase III CHAMPS
      study (see reference). This study was designed to determine if immediate initiation of
      therapy with Interferon Beta-1a (AVONEX) after a first attack of multiple sclerosis (MS)
      continues to delay the development of further attacks (CDMS) and the development of
      neurological disability over a 10 year period of observation. The initial 5 year extension
      study, called CHAMPIONS5, reported that immediate initiation of interferon Beta-1a (AVONEX)
      after a first attack of MS continued to delay the development of CDMS and lowered relapse
      rates compared to delayed initiation of disease modifying treatment (usually with AVONEX)
      either at the time of a second attack or at the end of the phase III study (24 months). The
      study was extended to 10 years to determine if these effects are sustained and result in less
      long term permanent disability.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previous participation in CHAMPS study

          -  Participation in a study site willing to participate in the CHAMPIONS10 extension
             study

          -  Willingness to enroll in the CHAMPIONS 10 extension

          -  Willingness to sign informed consent

        Exclusion Criteria:

          -  Discovery of an alternative neurological disorder other than MS as a cause of initial
             neurological symptoms

          -  A severe systemic disease with likely mortality within 3 years
Impact of Oral Application of Gastrografin on the Meconium Evacuation in Very Low Birth Weight Infants
Condition: Meconium Ileus; Very Low Birth Weight Infant
MeSH terms: Meconium Ileus; Body Weight; Birth Weight
Intervention: Gastrografin; Sterile water
Intervention description: Patients will receive 3ml Gastrografin + 6ml sterile water/kg as a single dose via a nasogastric tube during the first 24 hours of life.; Patients will receive 9ml/kg sterile water as a single dose via a nasogastric tube during the first 24 hours of life.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 96.0
Sex: All
Maximum age: 24 Hours
Healthy volunteers: No
Keywords: VLBW infant; Meconium; Enteral nutrition; Meconium passage

Summary:

      Gastrografin is a radiopaque contrast agent for the gastrointestinal tract (GIT) which can be
      applied orally or rectally. In neonatal intensive care, Gastrografin is used to detect
      otherwise radiologically invisible perforations or an insufficient GIT anastomosis after
      surgery. Furthermore it is used for the treatment of meconium ileus. Gastrografin has a
      strong osmotic effect and leads to water influx into the intestine lumen. Thereby the
      peristaltic movement is accelerated and the premature infant excretes stool during the hours
      following application. Therefore Gastrografin might be effective to mobilize meconium from
      small bowel and deep parts of the colon. The investigators hypothesized that enteral
      application of Gastrografin accelerates meconium evacuation in premature infants, and thereby
      enhances feeding tolerance in this population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  premature infants with a birthweight < 1500g and a gestational age < 32 weeks

        Exclusion Criteria:

          -  major congenital disorders

          -  chromosomal aberrations

          -  systemic metabolic disease and

          -  pre-existing gastrointestinal abnormalities (i.e. Morbus Hirschsprung)

          -  pre-existing conditions of severe hypotension
Quartet Lead and Resynchronization Therapy Options
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Cardiac Resynchronization Therapy Defibrillator
Intervention description: Cardiac Resynchronization Therapy Defibrillator
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this Clinical Trial is to determine the percentage of patients whose
      hemodynamic response improves with the different configurations offered by the new Quartet®
      left ventricular lead, as a result of its four electrodes, with respect to the configurations
      offered by a standard bipolar lead.

      Furthermore, the optimal stimulation configuration will be determined from a comparison with
      traditional configurations.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with a Cardiac resynchronization Therapy Defibrillator device (CRT-D) and a
             Quartet® quadripolar electrode from St Jude Medical (used in "Single Site Pacing"
             mode) implanted in the left ventricle.

          2. Patients who have provided written informed consent

          3. Patients who are in sinus rhythm.

          4. Patients older than 18 years of age.

        Exclusion Criteria:

          1. Patients in atrial fibrillation at the time of the echocardiographic study of the
             enrollment visit.

          2. Patients with valvular disease.

          3. Patients in functional class New York Heart Association (NYHA) IV

          4. Patients for whom echocardiography images suitable for determining the cardiac output
             cannot be obtained.

          5. Patients whose device has been changed/upgraded.

          6. Pregnant patients.

          7. Patients who do not fulfill all the inclusion criteria.

          8. Patients who are unable to provide written informed consent
A Post-marketing Study to Monitor the Safety of a MF59-adjuvanted Influenza Vaccine Administered in Korean Subjects Aged 65 Years or Older
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluad_MF59-adjuvanted trivalent influenza subunit vaccine; Vantaflu_MF59-adjuvanted trivalent influenza subunit vaccine
Intervention MeSH terms: Vaccines; MF59 oil emulsion
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 767.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the safety of an influenza (flu) vaccine in Korean men and women
      aged 65 years and older.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females aged 65 years and above on the day of enrollment, who were eligible
             for seasonal influenza vaccination.

          2. In the judgement of the study doctor are determined to be in reasonable health
             considering their age and able to comply with all study procedures.

        Exclusion Criteria:

          1. History of any serious reaction to flu vaccine, or any materials in the vaccine, and
             to eggs (including ovalbumin) and chicken protein.

          2. Receipt of another (inactivated) vaccine within 2 weeks, or receipt of a live vaccine
             within 4 weeks prior to Study Day 1, or planning to receive some other vaccination
             before the final study visit (about Day 29 after vaccination).

          3. Any condition, which in the opinion of the study doctor, might interfere with the
             evaluation of the study objective.
Effects of Lubiprostone on Small Bowel and Colonic Bacteria: A Correlation Study With Segmental and Whole Gut Transit
Condition: Constipation
MeSH terms: Constipation
Intervention: Lubiprostone
Intervention description: 24 mcg bid for 28 days
Intervention MeSH terms: Lubiprostone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Constipation; small intestinal bacterial overgrowth; stool bacteria

Summary:

      Patients with constipation often have bloating and abdominal distension. It is unclear if
      this is related to intestinal bacteria. Hypothesis: treatment for constipation may reduce
      small bowel and colon bacteria colonization, a change in the balance of stool microorganisms,
      and improve the symptoms of dyspepsia and constipation.
    

Eligibility criteria:

        Inclusion Criteria: Functional constipation by Rome III criteria

        Exclusion Criteria:

          1. History of esophageal or gastric surgery (including vagotomy, antireflux, and obesity
             surgery)

          2. History of small bowel or colon resection (excluding appendectomy and cholecystectomy)

          3. History of gastric outlet, small bowel, or colon obstruction

          4. History of surgery for small bowel adhesion lysis

          5. History of surgery for gastroparesis

          6. Diagnosis of diabetes requiring daily medications

          7. Diagnosis of connective tissue d/o (including scleroderma, lupus, mixed connective
             tissue disorder)

          8. Diagnosis of neuromuscular disorder (including multiple sclerosis, Parkinson, muscular
             dystrophy, dysautonomia, dystonia)

          9. Disorders of small bowel pseudo-obstruction or dumping syndrome

         10. Untreated or poorly controlled hypothyroidism

         11. Taking an opiate medication daily

         12. Taking a medication daily that can cause constipation (calcium channel blocker,
             anticholinergic, iron supplements, etc.)

         13. Active cancer being treated

         14. History of significant liver, kidney, cardiac disease that may interfere with study
             compliance

         15. Known allergy or side effects to lubiprostone

         16. Non-ambulatory patients: bed-ridden, nursing home resident, etc.
Alpha Lipoic Acid for Treatment of Diabetic Neuropathy
Condition: Diabetic Neuropathy
MeSH terms: Diabetic Neuropathies
Intervention: Alpha lipoic acid
Intervention description: Alpha lipoic acid 1800 mg PO divided in 3 doses for 4 weeks . If total symptoms score decreased >3 points patients received alpha lipoic acid 600 mg PO each day or no treatment for 16 weeks.
Intervention MeSH terms: Thioctic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Healthy volunteers: No

Summary:

      Patients with diabetic neuropathy and total symptoms score(TSS) >7 points were invited to
      this open multicenter study. Patients were free of pain medications and severe diabetic
      complications .Patients started alpha lipoic acid (ALA)1800 mg for 4 weeks. Patients with a
      decrease >3 points in the TSS were randomly allocated to 600 mg of ALA (ALA group) or no
      medications (ALA withdrawal) for 16 weeks. In each visit investigators evaluated any change
      in the TSS and the necessity of rescue medication to control symptoms (mainly pain). At the
      end of the study investigators compared between ALA and ALA withdrawal groups TSS levels and
      the frequency of use of rescue medications. Physicians were free to manage glucose to
      maintain Hba1c close to the ADA target (HbA1c <7%).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetic patients (according to American Diabetes Association (ADA) criteria)

          -  Symptomatic diabetic polyneuropathy

          -  Total Symptom Score (TSS) >7 points,

          -  HbA1c<10%,

          -  Serum creatinine <2 mg/dl.

        Exclusion Criteria:

          -  Active cardiovascular disease

          -  Malignancy

          -  Any other conditions causing neuropathic pain

          -  Use of analgesic, antidepressant, or antiepileptic drugs, or any other medication
             aimed to relief neuropathic pain.

          -  Child-bearing female patients not using any effective birth control method and under
             surveillance of a board-certified gynecologist
Preoperative Pain Control in Gastric Bypass Surgery Patients
Condition: Post-operative Pain
MeSH terms: Pain, Postoperative
Intervention: Pregabalin; Placebo (for Pregabalin)
Intervention description: One 300 mg oral dose of Pregabalin given before surgery.; One oral dose of placebo given before surgery.
Intervention MeSH terms: Pregabalin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Randomized clinical trial to evaluate whether a single pre-operative dose of Pregabalin will
      alleviate post-operative pain and decrease post-operative analgesic requirements in morbidly
      obese patients undergoing laparoscopic gastric bypass surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing laparoscopic Roux-en-Y gastric bypass surgery.

        Exclusion Criteria:

        -
Lab School Day Study for CONCERTA of Older Children With ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Placebo/ CONCERTA (methylphenidate HCl); CONCERTA (methylphenidate HCl) / Placebo
Intervention description: Placebo once daily on Lab School Day #1 and Optimal Subject Dose (18 mg-54 mg) once daily during Lab School Day #2; Optimal Subject Dose (18 mg-54 mg) once daily during Lab School Day #1 and Placebo once daily on Lab School Day #2
Intervention MeSH terms: Methylphenidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 78.0
Sex: All
Minimum age: 9 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: ADHD; Attention Deficit Hyperactivity Disorder

Summary:

      The purpose of this trial is to determine if the study medication, CONCERTA (methylphenidate
      HCl), is safe and effective in improving academic performance and behavior in children with
      attention deficit hyperactivity disorder (ADHD), when compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ADHD diagnosis of all subtypes (except Not Otherwise Specified)

          -  Patients with total or subscale Attention Deficit Hyperactivity Disorder Rating Scale
             (ADHD RS-IV) scores > =90th percentile relative to the general population of children
             by age and gender

          -  Patients currently receiving ADHD medication must be inadequately managed on their
             current stimulant dose and meet this criteria at the screening visit

          -  Ability to read and understand English

          -  Ability to attend school regularly.

        Exclusion Criteria:

          -  Estimated Full Scale IQ score of 80 or below

          -  Severe Learning Disability

          -  History of, or current, primary diagnosis of: severe anxiety disorder, conduct
             disorder, psychotic disorders, pervasive developmental disorder, eating disorder,
             obsessive-compulsive disorder, sleep disorder, major depressive disorder, bipolar
             disorder, substance use disorder, chronic tic disorder, personal or family history of
             Tourette's syndrome

          -  Weight < 3rd percentile for age

          -  History of hospitalization for treatment of a mood, anxiety, or psychotic disorder

          -  History of failed response to methylphenidate.
Intervention to Promote Weight Loss in Latinas At-risk for Diabetes
Condition: Diabetes
MeSH terms: Diabetes Mellitus; Weight Loss
Intervention: Promotora-led Intervention; Metformin Therapy; Usual Care
Intervention description: Behavioral life-style program lead by a team of trained community health workers (called promotoras) with 2 principal goals - encouraging participants to lose 7% of their total weight and complete 150 minutes of moderate physical activity per week.; Participants in this group will receive metformin 850 mg bid for one year.; Participants in this arm will attend one physician visit to discuss healthy lifestyle behaviors and will receive standard educational materials.
Intervention MeSH terms: Metformin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 92.0
Sex: Female
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The overarching goal of this project is to develop and test a behavioral intervention
      delivered by promotoras to help at-risk Latinas lose weight and prevent diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female gender

          -  Latino ethnicity

          -  Spanish fluency

          -  Age ≥20 years

          -  BMI ≥25 kg/m2

          -  And "increased risk of diabetes" (ADA Diabetes Risk Score ≥4 as determine by 7-item
             questionnaire and hemoglobin A1C ≥ 5.6%)

        Exclusion Criteria:

          -  Hemoglobin A1C ≥ 6.5%

          -  Current or planned pregnancy during the study period

          -  Chronic conditions that could affect potential participants' ability to participate
             (osteoarthritis, heart disease, pulmonary disease requiring oxygen or daily
             bronchodilator use, and severe psychiatric disease)

          -  Medical comorbidities that could influence weight loss or weight gain (thyroid
             disease, cancer, and HIV)

          -  Medications that could affect weight or glucose metabolism (thiazide diuretics,
             β-blockers, and systemic glucocorticoids).
Prophylactic Antibiotics in Admitted Cirrhotics
Condition: Cirrhosis, Liver
MeSH terms: Liver Cirrhosis; Fibrosis
Intervention: Ceftriaxone; Normal saline
Intervention description: Antibiotic; 50cc intravenous once daily
Intervention MeSH terms: Ceftriaxone
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blinded placebo-controlled trial
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      In this pilot study, the investigators aim to assess feasibility of subject identification
      and data collection, including specimen processing, as well as the rate of enrollment for a
      future, larger study of the effect of empiric antibiotics for all patients with advanced
      cirrhosis admitted to the hospital without an existing indication for new antibiotic use.
      Specifically, the investigators will assess the incidence of infection after the time of
      enrollment and associated outcomes. Subjects will be randomly assigned to receive antibiotics
      vs placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  MELD-Na >= 18

          -  Cirrhosis as defined by liver biopsy or a composite assessment of available results
             from imaging, elastography, prior records, and laboratory studies

        Exclusion Criteria:

          -  Inability to obtain consent (from subject or next of kin/legal authorized
             representative (LAR)

          -  Allergy to cephalosporins

          -  Pregnancy (due to limited prospective data regarding safety of ceftriaxone)

          -  Existing indication for new antibiotics, e.g. upper gastrointestinal hemorrhage or
             apparent infection

          -  Use of major immunosuppressive medications (e.g. prednisone 20 mg/day or greater,
             immunosuppression for solid organ transplant)

          -  H/o recurrent C difficile infection within the past year (>2) or requiring fecal
             microbiota transplant (FMT)

          -  Enrollment in the study protocol during a previous admission