bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Effect of a Single Infusion of VAY736 on Disease Activity in Patients With Relapsing-remitting Multiple Sclerosis
Condition: Relapse Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: VAY736; Placebo
Intervention description: Single intravenous infusion of VAY736 (10 mg/kg); Placebo to VAY736
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Multiple Sclerosis; Relapsing-Remitting Multiple Sclerosis; Magnetic Resonance Imaging; VAY736; Lanalumab; monoclonal antibody; gadolinium [Gd]-enhancing lesions; B-Cell

Summary:

      This was a randomized, partially blinded, placebo-controlled, non-confirmatory study to
      assess the effects of a single infusion of VAY736 on disease activity as measured by brain
      MRI scans in patients with relapsing-remitting multiple sclerosis (RRMS).
    

Eligibility criteria:

        Key inclusion criteria:

          -  Male and female patients aged 18 to 55 years.

          -  Diagnosis of MS as defined by the 2010 revised McDonald criteria (Polman et al 2011).

          -  A relapsing-remitting course of disease with:

               -  at least 1 documented relapse during the previous 12 months (but not within 30
                  days prior to randomization ), or

               -  a positive Gd-enhancing lesion on brain MRI scan at screening.

          -  An Expanded Disability Status Scale (EDSS) score of 0-5.0 inclusive at screening.

          -  No evidence of a relapse within 30 days prior to randomization.

        Key exclusion criteria:

          -  A manifestation of another type of MS other than RRMS.

          -  Findings on screening or baseline brain MRI inconsistent with the diagnosis of MS.

          -  History of chronic disease of the immune system other than MS, or a known
             immunodeficiency syndrome.

          -  Score "yes" on item 4 or item 5 of the Suicidal Ideation section of the C-SSRS, if
             this ideation occurred in the past 6 months, or "yes" on any item of the Suicidal
             Behavior section, except for the "Non-Suicidal Self-Injurious Behavior" (item also
             included in the Suicidal Behavior section), if this behavior occurred in the past 2
             years.

          -  Women of child-bearing potential and Pregnant or nursing (lactating) women.

          -  Screening CBC (complete blood count) laboratory values as follows:

          -  Hemoglobin levels below 10.0 g/dL

          -  Total leukocyte count less than 3,000 cells/µL

          -  Neutropenia, defined as absolute neutrophil counts less than 1500 cells/mm3

          -  Platelets less than 100,000/µL
A Safety and Efficacy Study to Determine if Giving Intravenous Fish Oil Helps Children With Liver Disease
Condition: Cholestasis
MeSH terms: Cholestasis
Intervention: Omegaven
Intervention description: 0.5 g/kg/d intravenous every day for 2 days, then 1 g/kg/d intravenous everyday
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 2 Weeks
Maximum age: 18 Years
Healthy volunteers: No
Keywords: liver; parenteral nutrition; fish oil; omegaven; children

Summary:

      The purpose of the study is to investigate if intravenous fish oil, commercially available as
      Omegaven, safely and effectively reverses parenteral nutrition associated cholestasis in
      children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical evidence of parenteral nutrition associated cholestasis

          -  Direct bilirubin greater or equal to 2 mg/dL on 2 consecutive measurements

          -  Expected parenteral nutrition course greater than 30 days

          -  Acquired or congenital gastrointestinal disease

          -  > 2 weeks of age and < 18 years of age

          -  > 60% calories from parenteral nutrition

          -  Failed standard therapies to prevent progression of liver disease (Actigal, cyclic
             parenteral nutrition, avoidance of overfeeding, reduction/removal of copper from
             parenteral nutrition if elevated my laboratory analysis, advancement of enteral feeds)

        Exclusion Criteria:

          -  Inborn errors of metabolism

          -  Extracorporeal Membrane Oxygenation

          -  Seafood, egg, or Omegaven allergy

          -  Documented case of liver disease other than Parenteral Nutrition Associated
             Cholestasis

          -  Hemorrhagic disorder

          -  Anticoagulant therapy

          -  Hemodynamically unstable or in shock

          -  Comatose state

          -  Stroke, pulmonary embolism, recent myocardial infarction

          -  Diabetes

          -  Fatal chromosomal disorder

          -  Enrollment in any other clinical trial involving an investigational agent

          -  Patient, parent, or legal guardians unable or unwilling to give consent

          -  Patient expected to be weaned from parenteral nutrition in 30 days

          -  unable to tolerate necessary monitoring

          -  Patient requiring aspirin or toradel or motrin

          -  Patient requiring dialysis
Oral Omadacycline vs. Oral Nitrofurantoin for the Treatment of Cystitis
Condition: Uncomplicated Urinary Tract Infection; Cystitis
MeSH terms: Urinary Tract Infections; Cystitis
Intervention: Omadacycline tablets; Nitrofurantoin capsules
Intervention description: Oral Omadacycline; Oral Nitrofurantoin
Intervention MeSH terms: Nitrofurantoin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 225.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of oral omadacycline as
      compared to oral nitrofurantoin in the treatment of female adults with cystitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female participants, age 18 or older who have signed the informed consent form

          -  Must have a qualifying uncomplicated urinary tract infection

          -  Participants must not be pregnant at the time of enrollment

          -  Must agree to a reliable method of birth control during the study and for 30 days
             following the last dose of study drug

        Exclusion Criteria:

          -  Males

          -  Evidence of complicated urinary tract infection (UTI), upper UTI, vaginitis, or
             sexually transmitted infection

          -  Evidence of significant immunological disease

          -  Has received an investigational drug within the past 30 days

          -  Participants who are pregnant or nursing
Study to Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention
Condition: Chronic Migraine or Episodic Migraine
MeSH terms: Migraine Disorders
Intervention: Placebo; AMG 301
Intervention description: Placebo was presented in identical containers, stored/packaged the same as AMG 301. All injections were administered within 30 minutes on treatment days.; AMG 301 was packaged in 5 mL clear glass vials containing 1 mL of 70 mg/mL of AMG 301. All injections were administered within 30 minutes on treatment days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 343.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Migraine; Headache; Prevention; Prophylaxis

Summary:

      To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period
      in monthly migraine days in subjects with migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults ≥ 18 to ≤ 60 years of age at the time of signing the informed consent form.

          -  History of migraine (with or without aura) for ≥ 12 months before screening according
             to the International Headache Society (IHS) Classification ICHD-III (Headache
             Classification Committee of the International Headache Society, 2013)

          -  Migraine frequency: ≥ 4 migraine days per month on average across the 3 months before
             screening.

          -  Failed at least 1 medication for prophylactic treatment of migraine due to
             tolerability or lack of efficacy

        Exclusion Criteria:

          -  Older than 50 years of age at migraine onset.

          -  History of cluster headache, hemiplegic migraine headache.

          -  Unable to differentiate migraine from other headaches.

          -  Migraine with continuous pain, in which the subject does not experience any pain-free
             periods (of any duration) during the 1 month before the screening period.

          -  History or evidence of any other clinically significant disorder, condition or disease
             that, in the opinion of the investigator or Amgen physician, if consulted, would pose
             a risk to subject safety or interfere with the study evaluation, procedures or
             completion.
Dose Ranging Study of BMS-945429 in Subjects With Moderate to Severe Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Placebo matching with BMS-945429; Placebo matching with BMS-945429; Placebo matching with BMS-945429; Placebo matching with BMS-945429; BMS-945429; BMS-945429; BMS-945429; BMS-945429; BMS-945429; BMS-945429; BMS-945429; BMS-945429; BMS-945429
Intervention description: Injection, Intravenous (IV), 0 mg, Day One Only, One Day; Injection, Subcutaneous (SC), 0 mg, Every 4 weeks, 8 weeks; Injection, Subcutaneous (SC), 0 mg, Week 4 Only, One Day; Injection, Subcutaneous (SC), 0 mg, Every 4 weeks, Up to 48 weeks; Injection, Intravenous (IV), 600 mg, Day One Only, One Day; Injection, Subcutaneous (SC), 200 mg, Week 8 only, One Day; Injection, Intravenous (IV), 300 mg, Day One Only, One Day; Injection, Subcutaneous (SC), 100 mg, Week 8 Only, One Day; Injection, Subcutaneous (SC), 400 mg, Day One and Week 4, 4 weeks; Injection, Intravenous (IV), 150 mg, Day One Only, One Day; Injection, Subcutaneous (SC), 100 mg, Every 4 weeks, Up to 48 weeks; Injection, Subcutaneous (SC), 200 mg, Every 4 weeks, Up to 48 weeks; Injection, Subcutaneous (SC), 200 mg, Every 4 weeks, Up to 96 weeks, depending on when subject enters this period
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to characterize the safety, efficacy and dose response of
      BMS-945429 in subjects with moderate to severe Crohn's disease and who have had an
      insufficient response to conventional therapy or have failed Anti-Tumor Necrosis Factor
      (anti-TNF) therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed Crohn's Disease diagnosis via radiology, endoscopy or histology within prior
             12 months. Diagnosed for at least 3 months

          -  Active Disease with Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450

          -  Failed conventional therapy or steroid dependent

        Exclusion Criteria:

          -  Diagnosed/clinical findings of Ulcerative Colitis (UC), indeterminate colitis, non
             colonic/ileal disease

          -  Stricture/stenosis, Stoma, proctocolectomy, subtotal colectomy, ileorectal anastomosis

          -  History of diverticulitis, or evidence of Gastrointestinal (GI) perforations
Safety Study of Danazol With Plasma Exchange and Steroids for the Treatment of Thrombotic Thrombocytopenic Purpura (TTP)
Condition: Thrombotic Thrombocytopenic Purpura
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombotic Thrombocytopenic
Intervention: Danazol
Intervention description: Danazol 600 mg PO will be initiated with plasma exchange and corticosteroids at the time of enrollment.
Intervention MeSH terms: Danazol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: TTP; Thrombotic Thrombocytopenic Purpura

Summary:

      The purpose of the study is to find out if administration of danazol with plasma exchange and
      corticosteroids will reduce the number of plasma exchanges required to control Thrombotic
      Thrombocytopenic Purpura (TTP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  TTP with platelets less than 100,000 and microangiopathic hemolytic anemia

          -  Age greater than 18 and less than 60

          -  LDH > 2x upper limit of normal

          -  PT and PTT normal

          -  Patients must give signed informed consent

          -  Pre-menopausal woman must have negative pregnancy test.

          -  TTP not related to underlying cancer, treatment of cancer or transplantation.

          -  TTP not associated with drugs.

        Exclusion Criteria:

          -  LFTs AST/ALT > 2x upper limit of normal

          -  Hepatitis B and Hepatitis C infection.

          -  HIV with active opportunistic infections

          -  Acute or chronic Disseminated Intravascular Coagulation (DIC), defined as D-dimer
             8ug/ml and fibrinogen<100 mg/dl

          -  TTP related to drugs, malignancy and transplantation.

          -  Pregnancy

          -  Concurrent other investigational drug use during this study.

          -  Porphyria.
Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Arm 1 stereotactic body radiation therapy; Arm II stereotactic body radiation therapy
Intervention description: Patients undergo 1 high-dose fraction; Patients undergo 3 high-dose fractions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage I non-small cell lung cancer; stage II non-small cell lung cancer

Summary:

      RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the
      tumor and cause less damage to normal tissue. It is not yet known which regimen of radiation
      therapy is more effective in treating patients with non-small cell lung cancer.

      PURPOSE: This randomized phase II trial is studying the side effects of two radiation therapy
      regimens and to see how well they work in treating patients with stage I or stage II
      non-small cell lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed non-small cell lung cancer

          -  T1-T2, N0 disease measuring ≤ 5 cm( T3 tumor based on chest wall involvement is
             Excluded)

          -  Surgically resectable primary disease, however patient evaluated by thoracic
             oncologist and deemed medically inoperable OR patient refuses surgical resection

          -  Age >= 18

        Exclusion Criteria:

          -  Prior thoracic radiation therapy

          -  T2 or T3 tumor greater than 5 cm or T3 tumor based on chest wall involvement

          -  Node positive or metastatic disease

          -  Tumor location within the zone of the proximal bronchial tree. The proximal bronchial
             tree is defined as the carina, right and left main bronchi, right and left upper lobe
             bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, and
             right and left lower lobe bronchi. The zone of the proximal bronchial tree is defined
             as a volume 2cm in all directions around the proximal bronchial tree.

          -  No other conditions deemed by the PI or associates to make the patient ineligible for
             protocol investigations, procedures, and high-dose external beam radiotherapy (e.g.,
             unable to lie still and breathe reproducibly)

          -  Pregnant or unwilling to use adequate contraception
Pupil Dilation for Treatment of IFIS
Condition: Intraoperative Floppy Iris Syndrome
MeSH terms: Mydriasis; Syndrome
Intervention: Brimonidine Tartrate
Intervention description: All subjects will apply brimonidine tartrate to one eye (right eye) only for the duration of study participation.
Intervention MeSH terms: Brimonidine Tartrate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: This is a single arm study in which all enrolled subjects will receive eye drops to only one eye. The alternative eye will serve as the control for efficacy.
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      A novel intervention for targeting the treatment of Intraoperative Floppy Iris Syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Adults (18 years old or greater) 3. History of having taken, or currently taking any
        systemic alpha blocker 2. Ability to consent themselves 3. Ability to apply eye drops
        themselves TID for 7 days

        Exclusion Criteria:

          1. Subjects with untreated hypertension or baseline BP >160

          2. Subjects with Thyrotoxicosis

          3. Pregnant women or women trying to conceive

          4. Prisoners

          5. Inability consent

          6. Subjects with anatomical narrow angles or who have never had a dilated eye exam

          7. Subjects currently prescribed brimonidine tartrate for glaucoma

          8. Subjects who take topical or systemic alpha agonists

          9. Patients who take monoamine oxidase (MAO) inhibitors

         10. Patients with known severe cardiovascular disease
Dose-ranging Efficacy and Pharmacokinetics Study of Intravenous Atorvastatin in Hypercholesterolemic Patients
Condition: Hypercholesterolemia; Dyslipidemias
MeSH terms: Hypercholesterolemia; Dyslipidemias
Intervention: Atorvastatin injection
Intervention description: statin (i.e., 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor) for injection
Intervention MeSH terms: Atorvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Open-label study will titrate doses of intravenous atorvastatin and monitor respective LDL-C
      levels in hypercholesterolemic patients previously controlled on oral atorvastatin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  On stable dose of daily oral atorvastatin for >= 5 weeks (oral atorvastatin may be
             provided during a lead-in period for subjects not previously taking atorvastatin)

          -  Stable LDL-C confirmed in the previous 7 to 10 days prior to enrollment into the
             treatment phase.

        Exclusion Criteria:

          -  History of myopathy or rhabdomyolysis

          -  Liver disease including current biliary disorders

          -  Positive for HIV, Hepatitis B or Hepatitis C Virus

          -  Abuse of alcohol or non-prescribed drugs

          -  Unstable angina or arrhythmias or a cardiac event in the previous three months

          -  hypothyroidism, diabetes, or hypertension that is not under control

          -  pregnant or plans to be pregnant
Dose-Ranging Study to Evaluate Efficacy and Safety of Weekly CJC-1134-PC in Patients With T2DM on Metformin Monotherapy
Condition: Type 2 Diabetes Mellitus (T2DM)
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: CJC-1134-PC Injection; Weekly placebo for CJC-1134-PC Injection
Intervention description: CJC-1134-PC administered weekly by subcutaneous injection; Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
Intervention MeSH terms: Metformin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes Mellitus; T2DM; diabetes; ConjuChem; GLP-1; Glucagon-like peptide-1; exendin-4; modified exendin-4

Summary:

      DM200-103 is a dose-ranging study to evaluate the efficacy and safety of 17 weeks of weekly
      injections of CJC-1134-PC in patients with Type 2 Diabetes Mellitus on metformin monotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women 18 to 70 years of age, inclusive

          -  Body mass index of 27 to 45 kg/m2

          -  Diagnosed with T2DM for at least 6 months before screening

          -  Stable daily dose of metformin monotherapy of ≥1000 mg for at least 3 months before
             screening

          -  FPG ≤240 mg/dL at screening

          -  HbA1c ≥7.0% and ≤11% at screening

          -  A 12-lead electrocardiogram recording without clinically significant arrhythmia, left
             bundle-branch block, or corrected QT interval

        Exclusion Criteria:

          -  Pregnant or breastfeeding women

          -  Use of a weight control treatment, including over-the-counter medications (includes
             herbal supplements), or a significant change in body weight (at least ±10%) in the 3
             months before screening

          -  Treatment with any oral antidiabetic agent other than metformin within the 3 months
             before screening

          -  Treatment with insulin for longer than 1 week within the 3 months before screening or
             any treatment with insulin within the 2 weeks before screening

          -  Previous treatment with a glucagon-like peptide 1 (GLP-1) analog or other incretin
             therapy

          -  Receipt of any experimental drug in a clinical trial within 30 days before
             administration of study drug or receipt of any investigational antidiabetic product
             within 3 months before screening