bioihbjkbjnl/mcl2 huggingface dataset:
Irritable Bowel Syndrome With Diarrhea (IBS-D) Rifaximin Re-Treatment Study
Condition: Irritable Bowel Syndrome With Diarrhea
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Intervention: open-label rifaximin; double-blind placebo; double-blind rifaximin
Intervention description: 550 mg three times a day (open-label); 3 times a day (double-blind); 550 mg three times a day (double-blind)
Intervention MeSH terms: Rifaximin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2583.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IBS; IBS-D; IBS with diarrhea; Diarrhea; Irritable bowel syndrome with diarrhea

Summary:

      This study will evaluate the effectiveness and safety of repeat treatment with rifaximin 550
      mg three times a day in patients with IBS with diarrhea who respond to initial treatment of
      rifaximin 550 mg three times a day.
    

Eligibility criteria:

        Inclusion Criteria:

          -  IBS confirmed by Rome III diagnostic criteria.

          -  At least 18 years of age.

          -  Colonoscopy within the past 10 years to rule out inflammatory bowel disease; or
             flexible sigmoidoscopy if < 50 years of age or previous colonoscopy > 10 years prior.

          -  Willing to maintain a stable diet. including vitamins, supplements, and
             nutraceuticals.

        Exclusion Criteria:

          -  Diabetes (Type 1 or 2).

          -  Lactose intolerance and not controlled by a lactose-free diet.

          -  Pregnant or planning to become pregnant or is lactating.

          -  History of HIV or hepatitis B or C.

          -  Participation in investigational study within past 30 days.

          -  Taking rifaximin or any other antibiotic within past 60 days.

          -  Unstable cardiovascular or pulmonary disease, with change in treatment in last 30 days
             due to worsening disease condition.

          -  History of GI surgery.
Suprachoroidal Injection of Triamcinolone Acetonide With IVT Anti-VEGF in Subjects With Macular Edema Following RVO
Condition: Macular Edema; Retinal Vein Occlusion
MeSH terms: Macular Edema; Retinal Vein Occlusion; Edema
Intervention: suprachoroidal CLS-TA; suprachoroidal sham; Lucentis or Avastin
Intervention description: suprachoroidal injection of CLS-TA; sham suprachoroidal procedure; IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Bevacizumab; Ranibizumab; Triamcinolone diacetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 325.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: RVO; ME; Microneedle; Microinjection; Triamcinolone; Choroid; Choroid injection; Suprachoroidal; Anti-VEGF; Subretinal Fluid; Cystoid Macular Edema; Optical Coherence Tomography; OCT; Central Subfield Thickness; Lucentis; Avastin; Ranibizumab; Bevacizumab; Triamcinolone acetonide

Summary:

      This Phase 3, multicenter, randomized, masked, controlled, parallel group study is designed
      to demonstrate that suprachoroidal (SC) CLS-TA administered with intravitreal (IVT) anti-VEGF
      agent in subjects with treatment naive RVO is superior to IVT anti-VEGF agent used alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a clinical diagnosis of RVO in the study eye

          -  Has a CST of ≥ 300 µm in the study eye

          -  Has an ETDRS BCVA score of ≥ 20 letters read and ≤ 70 letters read in the study eye

          -  Is naïve to local pharmacologic treatment for RVO in the study eye

        Exclusion Criteria:

          -  Any active ocular disease or infection in the study eye other than RVO

          -  History of glaucoma, intraocular pressure > 21 mmHg or ocular hypertension requiring
             more than one medication

          -  Any uncontrolled systemic disease that, in the opinion of the Investigator, would
             preclude participation in the study

          -  Any evidence of neovascularization in the study eye
Oral HYCAMTIN Plus Whole Brain Radiation Therapy In Treatment Of Brain Metastases Resulting From Non-Small Lung Cancer
Condition: Lung Cancer, Non-Small Cell
MeSH terms: Lung Neoplasms; Neoplasm Metastasis; Brain Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: HYCAMTIN, oral capsules; Radiation
Intervention description: topotecan oral capsules 1.1 mg/m2; Whole brain radiation
Intervention MeSH terms: Topotecan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 472.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Brain metastases from Non-Small Cell Lung Cancer; Brain metastases brain tumor lung cancer oral chemotherapy HYCAMTIN topotecan NSCLC WBRT whole brain radiation

Summary:

      The current prognosis for patients with metastatic brain cancer from NSCLC is very poor. The
      current standard treatment for this disease is radiation therapy to the brain. The goal of
      the current study is to test whether the combination of orally administered HYCAMTIN capsules
      and whole brain radiation therapy will prolong the survival time of patients with this
      potentially serious condition.
    

Eligibility criteria:

        Inclusion criteria:

          -  At least one measurable cancerous lesion in the brain from primary non-small cell lung
             cancer (NSCLC)

          -  Must have received previous chemotherapy

          -  Must be 18 years of age of greater

          -  Must be Easter Cooperative Oncology Group (ECOG) Performance Status 0, 1, 2

          -  At least 2 weeks must have elapsed since any surgery

          -  At least 4 weeks must have elapsed since any radiation to a non-CNS site

          -  Must have adequate bone marrow, renal, and live capacities

          -  Women must be of non-childbearing potential or practice adequate birth control

          -  Males must practice adequate methods of birth control

          -  Must sign written informed consent

        Exclusion criteria:

          -  Previous whole brain radiation therapy

          -  Prior treatment with topotecan

          -  Investigational agent within 30 days or 5 half-live

          -  Concomitant therapy with inhibitors of breast cancer resistance protein (BCRP) or
             P-glycoprotein such as erlotinib or gefitinib

          -  Primary or secondary immunodeficiencies

          -  Gastrointestinal conditions that affect GI absorption or motility

          -  Uncontrolled emesis

          -  Brain metastasis at time of initial diagnosis of NSCLC

          -  History of other malignancy except in situ carcinoma of cervix; nonmelanomatous skin
             cancer, low grade prostate cancer

          -  Pregnant or intending to become pregnant or intending to father a baby

          -  Any severe concurrent medical condition that could affect compliance.
Open-label Study to Evaluate the Safety and Tolerability of iv Lacosamide in Japanese Adults With Partial-onset Seizures
Condition: Epilepsy; Partial-onset Seizures
MeSH terms: Epilepsy; Seizures
Intervention: Lacosamide (200 mg/20 mL)
Intervention description: Active Substance: Lacosamide
Pharmaceutical form: Solution for intravenous (iv) infusion
Concentration: adapted on concentration of oral dose in EP0009
Route of Administration: Drip infusion
Intervention MeSH terms: Lacosamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Lacosamide; LCM; Epilepsy; Partial-onset seizures; iv

Summary:

      EP0024 is a Phase 3, multicenter, open-label study to evaluate the safety and tolerability of
      intravenous (iv) lacosamide (LCM). Adjunctive iv LCM therapy (200 mg/day to 400 mg/day) will
      be administered for 5 days as replacement for oral LCM tablets in Japanese adults with
      partial-onset seizures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is Japanese and enrolled in EP0009 (NCT01832038) receiving oral Lacosamide
             (LCM) for the treatment of partial-onset seizures and has been enrolled for at least 8
             weeks

          -  Subject has been on a stable twice daily (bid) dosage regimen of LCM 200 mg/ day to
             400 mg/ day, for the 2 weeks prior to entry into EP0024

          -  Subject has been receiving no more than 3 concomitant Antiepileptic Drugs (AEDs) at
             doses that have remained stable for the 2 weeks prior to entry into EP0024

        Exclusion Criteria:

          -  Subject has a history of any kind of status epilepticus within 12-month period prior
             to study entry

          -  Subject has actual suicidal ideation as indicated by a positive response ("Yes") to
             either Question 4 or Question 5 of the "Since Last Visit" version of the
             Columbia-Suicide Severity Rating Scale (C-SSRS)
A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features
Condition: Bipolar I Disorder; Mania; Depression
MeSH terms: Recurrence; Depression
Intervention: Cariprazine; Placebo
Intervention description: Cariprazine capsules, oral administration, once daily; Matching placebo capsules, oral administration, once daily
Intervention MeSH terms: Cariprazine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 901.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      1) To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/day compared
      with placebo in prevention of relapse in patients with bipolar I disorder whose current
      episode (i.e. index episode) is manic or depressive, with or without mixed features; 2) To
      evaluate the efficacy and safety of cariprazine at a target dose of 1.5 mg/day compared with
      placebo in prevention of relapse in patients with bipolar I disorder whose current episode
      (i.e. index episode) is manic or depressive, with or without mixed features who were
      initially stabilized on a target dose of 3.0 mg/day
    

Eligibility criteria:

        Inclusion Criteria:

          -  Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth
             Edition (DSM-5) criteria for bipolar I disorder, and at least one of the following two
             criteria:

          -  Current episode manic, with or without mixed features, having a total Young Mania
             Rating Scale (YMRS) total score ≥ 20 and a score of at least 4 on 2 YMRS items
             (irritability, speech, content, or disruptive/aggressive behavior);

          -  OR current episode depressive, with or without mixed features, having a
             Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥ 23 and a score of at
             least 3 on 2 MADRS items (apparent sadness, reported sadness, inner tension or
             inability to feel).

        Exclusion Criteria:

          -  Four or more episodes of a mood disturbance within the 12 months before Visit 1;

          -  Diagnosis of another psychiatric disorder other than bipolar disorder with the
             exception of specific phobias.
A Study of the Safety and Efficacy of Infliximab(REMICADE ) in Pediatric Patients With Moderately to SeverelyActive Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: infliximab; infliximab; infliximab; infliximab
Intervention description: infusion of 5mg/kg at weeks 0, 2, 6 followed by every 12 wks through week 42; infliximab - Could receive infusion of 10mg/kg every 8 weeks up to week 42; infliximab - Could receive infusion of 5mg/kg every 8 weeks up to week 42; infusion of 5mg/kg at weeks 0, 2, 6 followed by every 8 wks through week 46; infliximab - Could receive infusion of 10mg/kg every 8 weeks up to week 46; infliximab - Could receive infusion of 10 mg/kg every 8 weeks up to week 42; infusion of 5mg/kg at weeks 0, 2, 6, then every 12 wks through week 42
Intervention MeSH terms: Infliximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Ulcerative colitis; inflammatory bowel disease; children

Summary:

      The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade)
      in children with moderately to severely active ulcerative colitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have moderately to severely active ulcerative colitis

          -  Diagnosed with ulcerative colitis for 2 weeks before screening

          -  Male patients who are sexually active and female patients who are sexually active or
             of childbearing potential must use adequate birth control while participation in the
             study and for 6 months after the last infusion.

        Exclusion Criteria:

          -  History of latent or active TB

          -  Have had a live viral or bacterial vaccination within 3 months before screening

          -  Have or have had serious infections within 3 months before screening

          -  Prior treatment with infliximab
Duloxetine Versus Placebo in Chronic Low Back Pain
Condition: Back Pain Without Radiation
MeSH terms: Back Pain; Low Back Pain
Intervention: Duloxetine; Placebo
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 404.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of your participation in this study is to help answer the following
      research question, and not to provide you treatment for your condition--Whether duloxetine
      once daily can help patients with Chronic Low Back Pain.
    

Eligibility criteria:

        Inclusion Criteria: - Male/Female outpatients 18 years of age with chronic low back pain.
        Exclusion Criteria: - You have a serious or unstable disease of the heart or blood vessels,
        liver, kidney, lungs, or blood-related illness, problems with decreased blood flow to arms
        and legs (peripheral vascular disease), or other medical conditions, or psychiatric
        conditions that, in the opinion of the investigator, would affect your participation or be
        likely to lead to hospitalization during the course of the study. - Have acute liver injury
        (such as hepatitis) or severe cirrhosis. - Have had previous exposure to duloxetine. - Have
        a body mass index (BMI) over 40. - Have major depressive disorder. - Require daily
        narcotics.
Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Asian Patients With Essential Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: LCZ696; Olmesartan; Placebo of LCZ696; Placebo of Olmesartan
Intervention description: LCZ696 200 mg tablet; Olmesartan 20 mg capsule; Placebo tablet of LCZ696 200 mg once daily; Placebo capsule of olmesartan 20 mg once daily
Intervention MeSH terms: Olmesartan; Olmesartan Medoxomil; Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1438.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Essential hypertension; LCZ696

Summary:

      This study will assess the efficacy and safety of multiple doses of LCZ696 compared to
      olmesartan in Asian patients with essential hypertension
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with mild-to-moderate hypertension, untreated or currently taking
             antihypertensive therapy.

          -  Treated patients (using antihypertensive treatments within 4 weeks prior to Visit 1)
             must have an msSBP≥150 mmHg and <180 mmHg at the randomization visit (Visit 201) and
             msSBP≥140 mmHg <180 mmHg at the visit immediately preceding Visit 201 (Visit 102 or
             103).

          -  Untreated patients (newly diagnosed with essential hypertension or having a history of
             hypertension but have not been taking any antihypertensive drugs for at least 4 weeks
             prior to Visit 1) must have an msSBP≥150 mmHg and <180 mmHg at both Visit 1 and Visit
             201.

          -  Patients must have an absolute difference of ≤15 mmHg in msSBP between Visit 201 and
             the immediately preceding visit.

        Exclusion Criteria:

          -  Patients with severe hypertension (msDBP ≥110 mmHg and or msSBP ≥180 mmHg).

          -  History of angioedema, drug-related or otherwise, as reported by the patient.

          -  History or evidence of a secondary form of hypertension, including but not limited to
             any of the following: renal parenchymal hypertension, renovascular hypertension
             (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary
             hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease,
             and drug-induced hypertension.

          -  Patients who previously entered a LCZ696 study and had been randomized or enrolled
             into the active drug treatment epoch.

        Other protocol-defined inclusion/exclusion criteria may apply.
KIDCARE (Kawasaki Disease Comparative Effectiveness Trial)
Condition: Mucocutaneous Lymph Node Syndrome
MeSH terms: Mucocutaneous Lymph Node Syndrome
Intervention: IVIG; Infliximab
Intervention description: Subjects randomized to this arm will receive IVIG 2g/kg over 10-12 hours; Subjects randomized to this arm will receive infliximab 10 mg/kg over 2 hours
Intervention MeSH terms: Infliximab; Immunoglobulins; Immunoglobulins, Intravenous; gamma-Globulins; Rho(D) Immune Globulin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 105.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Kawasaki disease

Summary:

      Kawasaki disease (KD) is a self-limited illness that affects the heart blood vessels
      (coronary arteries) of infants and children and is now the most common cause of acquired
      heart disease in children. A mixture of proteins from human blood (Intravenous
      immunoglobulin, IVIG) is a treatment that reduces the rate of the major complication of the
      disease: a bulging of the wall of the coronary arteries called an aneurysm. However, 10-20%
      of children are resistant to this treatment and the fever returns. These children have the
      highest rates of aneurysm formation and thus should be treated aggressively. Unfortunately,
      there are no guidelines for the best secondary treatment for these resistant patients because
      the problem has never been adequately studied. Most physicians choose either a second
      infusion of IVIG or an engineered antibody called infliximab that inactivates a molecule that
      promotes inflammation. This trial will randomize (assign by chance like the flip of a coin)
      IVIG-resistant patients to receive either a second IVIG infusion or infliximab and the
      response to treatment will be compared to learn which treatment stops the fever the fastest.
      In addition, parents and caregivers will provide observations about their child's response to
      the different treatments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eligible subjects will be as follows:

               1. 4 weeks to 17 years of age,

               2. fulfill the American Heart Association case definition for complete or incomplete
                  KD,

               3. have had fever (T ≥38°C) for 3 to 10 days prior to initial IVIG treatment,

               4. have fever (T ≥38°C orally or rectally) between 36 hours and 7 days after end of
                  the first IVIG infusion without other likely cause

        Exclusion Criteria:

          1. Patient treated with infliximab or steroids for present illness (pts who received oral
             steroids as outpatients prior to KD diagnosis but who otherwise qualify for the study
             will not be excluded)

          2. Known prior infection with tuberculosis, coccidiomycosis, or histoplasmosis.