bioihbjkbjnl/mcl2 huggingface dataset:
C. Difficile and Ursodiol
Condition: Diarrhea
MeSH terms: Diarrhea
Intervention: Ursodiol
Intervention description: Subjects will begin to take 300 mg Ursodiol 2 (two) weeks after Visit #1 for a total of 8 (eight) weeks.
Intervention MeSH terms: Ursodeoxycholic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Colitis; Bile

Summary:

      In vitro findings have established that ursodeoxycholic acid is a surrogate for deoxycholic
      acid in preventing the growth of C. difficile, and interrupting recurrence. Investigators
      will administer ursodeoxycholic acid for two months, beginning with Metronidazole and/or
      Vancomycin (8 to 10 days), antibiotics currently used for the treatment of acute C.Difficile
      infection. Ursodeoxycholic acid prevents c.difficile recurrence by (a) directly suppressing
      the growth of C. Difficile and (b) permitting restoration of normal fecal bile acid
      composition (80% deoxycholic acid) to maintain growth suppression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients with recurrent C. difficile colitis

          -  18 years of age and older

          -  Capable of giving informed consent

        Exclusion Criteria:

          -  Patients with other gastrointestinal problems prone to cause diarrhea if they cannot
             be controlled for the period of the study. Lactose intolerance or gluten enteropathy
             are not an exclusion provide that the potential subject is asymptomatic and can be
             expected to adhere to the appropriate dietary regimen.

          -  Patients with contraindications to metronidazole or vancomycin and/or ursodiol tablets
             or components of the formulations.

          -  Patients not available for long-term follow-up (2 months) by their physician will be
             excluded from the study.
Effectiveness of On-demand Meteospasmyl® Use in Irritable Bowel Syndrome (IBS)
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Intervention: anti spasmodic agents; alverine citrate, simeticone
Intervention description: best standard of care prescriptions; on-demand therapy
Intervention MeSH terms: Mebeverine; Alverine; Parasympatholytics
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 436.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the effectiveness of 2 IBS treatment strategies:

        -  Strategy A = MeteoSpasmyl®, on-demand therapy

        -  Strategy B = standard of care chosen by the physician
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female ambulatory patients, aged >= 18 years

          -  with IBS as defined by Rome III criteria for more than 1 year and less than 10 years

          -  with a IBS-SSS between 175 and 400

        Exclusion Criteria:

          -  Acute diarrhea, bowel disorders due to an underlying cause

          -  Patient treated with MeteoSpasmyl® within the past 6 months

          -  Recent history of gastro intestinal surgery
Open-label Study of Subcutaneous Secukinumab to Evaluate Efficacy and Safety in Patients With Plaque Psoriasis Who Had Inadequate Response to Cyclosporine A
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Secukinumab (AIN457)
Intervention description: Secukinumab was supplied as 150 mg doses, provided in 1 mL prefilled syringes.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cyclosporine A

Summary:

      The purpose of this study was to assess the efficacy and safety of secukinumab at Week 16
      based on psoriasis area and severity index (PASI) 75 in subjects who had inadequate response
      to cyclosporine A.
    

Eligibility criteria:

        Inclusion criteria:

          -  Plaque psoriasis diagnosed for at least 6 months before baseline - Treated with
             cyclosporine A for at least 12 weeks prior to baseline

          -  Currently treated with cyclosporine A at baseline for psoriasis but is a primary or
             secondary inadequate response as defined at baseline by:

               -  PASI score of 10 or greater and

               -  IGA mod 2011 score of 2 or greater (based on a scale of 0 to 4)

        Exclusion Criteria:

          -  Forms of psoriasis other than plaque (e.g., pustular, erythrodermic and guttate
             psoriasis). -Drug-induced psoriasis (i.e., new onset or current exacerbation from
             beta-blockers, calcium channel blockers or lithium).

          -  Patients who have to discontinue cyclosporine A treatment due to side effects like
             renal impairment (serum creatinine exceeding 176.8 μmol/L [2.0 mg/dL]) and
             hypertension at screening.

        Other protocol-defined inclusion/exclusion criteria may apply
Effect of Licorice and Hydrochlorothiazide on Plasma Potassium
Condition: Hypokalemia
MeSH terms: Hypokalemia
Intervention: Hydrochlorothiazide; Licorice
Intervention description: Hydrochlorothiazide 25 mg a day for 14 days.; Licorice candy 32 grams a day for 14 days.
Intervention MeSH terms: Hydrochlorothiazide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This clinical trial is designed to study the effect of the combination of licorice and
      hydrochlorothiazide on plasma potassium levels in volunteers. In one arm, 10 healthy
      volunteers will be given 32 grams of licorice a day together with a 25 mg dose of daily
      hydrochlorothiazide for 14 days. This combination is compared with 32 grams of licorice a day
      for 14 days given in the other arm. The study is a randomized, open-label cross-over trial.
      There is at least a 3-week wash-out between the arms. The hypothesis is that the combination
      of licorice and hydrochlorothiazide will cause hypokalemia. The main outcome measure is the
      change in the plasma level of potassium between the arms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy volunteer

          -  Age 18-40 years

        Exclusion Criteria:

          -  Any continuous medication

          -  Any significant disease

          -  Hypotension or hypertension

          -  Allergy to licorice or hydrochlorothiazide

          -  Pregnancy and breast feeding

          -  Fear of needles and previous difficult blood samplings

          -  Substance abuse

          -  Participation in another clinical drug trial within 1 month of enrollment
Gene Regulation by Thiazolidinediones
Condition: Inflammatory Bowel Disease
MeSH terms: Inflammatory Bowel Diseases
Intervention: Rosiglitazone
Intervention description: 8mg tablet once a day for 14 days
Intervention MeSH terms: Rosiglitazone
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine the effect of rosiglitazone on the genes of the
      colon
    

Eligibility criteria:

        Inclusion Criteria:

          -  Capable of giving informed consent

          -  Agrees to use a barrier method of birth control for the duration of the study

        Exclusion Criteria:

          -  History of inflammatory bowel disease

          -  Has taken prescription or over the counter medications in the two weeks prior to
             enrollment

          -  History of diabetes, heart failure, angina, hypertension, coronary heart disease,
             cancer, bleeding disorder, HIV, AIDS

          -  Fasting LDL >160 mg/dl

          -  History of smoking in the year prior to enrollment

          -  Pregnant or breastfeeding
Atomoxetine for Treating Attention Deficit Hyperactivity Disorder in Young Children
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Atomoxetine; Placebo; Parent Training
Intervention description: Participants will receive atomoxetine for 8 weeks up to a maximum of 1.8 mg/kg/day. Dosed once daily in capsule formulation.; Participants will receive placebo for 8 weeks. Dosed once daily, capsule formulation.; All children will receive parent training for the duration of the study.
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 93.0
Sex: All
Minimum age: 5 Years
Maximum age: 6 Years
Healthy volunteers: No
Keywords: ADHD; Atomoxetine

Summary:

      This study will evaluate the effectiveness of atomoxetine in reducing the symptoms of
      attention deficit hyperactivity disorder (ADHD) in young children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Parent and child must be English speaking

          -  Child has been living with parent/guardian for at least six months

          -  Meets criteria for ADHD on the DISC, on clinical interview, and on clinical consensus
             conference

          -  ADHD is primary disorder with symptoms present for at least 9 months

          -  ADHD-IV-Rating Scale (ADHD-IV-RS)score that is at least 1.5 standard deviations above
             age and sex norms

          -  Score of 55 or below on the Children's Global Assessment Scale

          -  Score of 4 or greater on the Clinical Global Impression Scale

          -  Estimated Intelligence Quotient (IQ) of 70 or greater

          -  Currently participating in school at least 2 half-days per week

          -  Able to identify a teacher who can make valid assessments

          -  Patient and parent are able to attend regular study visits

        Exclusion Criteria:

          -  Currently taking other psychotropic medications or other medications with effects on
             the central nervous system

          -  Currently being treated effectively with atomoxetine

          -  Major medical conditions that might interfere with study medications

          -  History of or current clinically significant kidney illness

          -  Evidence of adjustment disorder, autism, psychosis, bipolar disorder, suicide
             ideations, or any other psychiatric disorder requiring treatment with additional
             psychotropic medication

          -  History of physical, sexual, or emotional abuse impacting clinical presentation

          -  Prior failure to respond to an adequate trial of atomoxetine
Efficacy and Safety Study of BOTOX® Compared to Topiramate for the Prevention of Chronic Migraine in Adults
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Intervention: onabotulinumtoxinA; Topiramate
Intervention description: 155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks.; Topiramate up to a maximum oral dose of 100 mg/day.
Intervention MeSH terms: Topiramate; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 282.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy, safety and tolerability of prophylactic (preventative)
      treatment with BOTOX® (onabotulinumtoxinA) compared to topiramate in adults with chronic
      migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of chronic migraine

          -  More than 15 headache days in a 28 day period (headaches that last more than 4 hours
             and/or require treatment with prescription medication).

        Exclusion Criteria:

          -  Taking opioid-containing products for acute headache treatment more than 8 days during
             a 28-day period

          -  Previous treatment with botulinum toxin of any serotype for any reason

          -  Previous treatment with topiramate

          -  On a ketogenic diet (high in fat, low in carbohydrates)

          -  History of acute myopia or increased intraocular pressure

          -  Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
             or any other significant disease that might interfere with neuromuscular function

          -  Acupuncture, transcutaneous electrical stimulation (TENS), cranial traction, dental
             splints for headache, or injection of anesthetics/steroids in the 4 weeks prior to
             screening.
A Double Blind Study Comparing Hyaluronic Acid, Corticosteroid and Placebo During Arthrocentesis for Temporomandibular Joint (TMJ) Dysfunction
Condition: Temporomandibular Joint Dysfunction; Pain; Arthrocentesis
MeSH terms: Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Intervention: Hyaluronic acid; Corticosteroid; Lactated Ringers
Intervention description: 1 cc hyalgan to be injected into superior joint space; 1cc celestone (6 mg/cc) will be injected into the joint space; 1 cc lactated ringers solution will be injected into the joint space
Intervention MeSH terms: Hyaluronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether the administration of hyaluronic acid or
      corticosteroid during arthrocentesis of the temporomandibular joint provides additional pain
      relief and improved function.

      The overall hypothesis for the study is that hyalgan will result in a 30% reduction in the
      mean visual analogue scale (VAS) at one month when compared to celestone and placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age greater than 18 years

          -  arthralgia of one or both temporomandibular joints

          -  Wilkes II to IV internal derangement of the symptomatic joint OR

          -  limited opening of <35 mm

        Exclusion Criteria:

          -  myofascial pain as the primary source of pain

               -  cervical pain as the primary source of pain

          -  systemic arthropathy

          -  fibromyalgia

          -  use of NSAIDS within 48 hours

          -  allergy to study medications

          -  edentulous subjects

          -  pregnancy or breast feeding

          -  current physical therapy, muscle relaxants or antiseizure medications

          -  current use of a splint issued within last 12 weeks