bioihbjkbjnl/mcl2 huggingface dataset:
Double-Blind, Placebo-Controlled Study of Two Doses of EPA-E in Patients With Non Alcoholic Steatohepatitis (NASH)
Condition: Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: Placebo capsule; EPA-E 300 mg capsule; EPA-E 300 mg capsule
Intervention description: 3x Placebo capsules three times a day (TID) for 365 days; 2x 300 mg capsules + placebo capsule TID for 365 days; 3x 300 mg capsules TID for 365 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 243.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: omega-3 fatty acids; alanine transaminase; triglycerides; lipids; EPA; ethyl-EPA; ethyl icosapentate; Non Alcoholic steatohepatitis; Non Alcoholic fatty liver disease; fatty acids

Summary:

      This is a controlled study to determine the effectiveness and safety of ethyl icosapentate
      (EPA-E) in the treatment of adult patients with non-alcoholic steatohepatitis (NASH).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of definite NASH

          -  Patients with diabetes taking stable doses of anti-diabetic agents are eligible

          -  No significant concomitant medical illness

        Exclusion Criteria:

          -  Diagnosis of cirrhosis.

          -  Serum ALT > 300 U/L

          -  Use of drugs associated with steatohepatitis

          -  Use of the following anit-NASH agents:

               1. Vitamin E > 60 IU per day

               2. Omega-3-acid ethyl esters or omega-3-polyunsaturated fatty acid (PUFA)-containing
                  supplements > 200 mg per day

               3. Thiazolidinediones (e.g. pioglitazone)

          -  Use of non-stable doses of the following anti-NASH agents: HMGCoA reductase inhibitors
             (statins), fibrates, probucol, ezetimibe, ursodiol (UDCA), taurine, betaine,
             N-acetylcysteine, s-adenosylmethionine (SAM-E), milk thistle, anti-TNF therapies, or
             probiotics.

          -  Other liver disease
Sapropterin as a Treatment for Autistic Disorder
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Intervention: sapropterin; Placebo
Intervention description: Patients will receive sapropterin 20 mg per kilogram per day for 16 weeks; Patients will receive a placebo identical in form and dosage to the active drug daily for 16 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 46.0
Sex: All
Minimum age: 3 Years
Maximum age: 6 Years
Healthy volunteers: No
Keywords: autism

Summary:

      This study is intended to provide a definitive test of the hypothesis that elevating
      sapropterin (tetrahydrobiopterin, a cofactor for several key brain enzymes)concentrations in
      the CNS will result in measurable improvements in core symptoms of autism in young
      individuals, under age 6 years. The study will entail a double-blind, placebo-controlled
      16-week intervention.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Parents sign informed consent

          -  Child meets criteria for autistic disorder (based on score on the Autism Diagnostic
             Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule (ADOS), given
             by a certified administrator, research reliable)

          -  Child has a Developmental Quotient (DQ) ≥ 50 (Vineland Adaptive Scales, Interview
             Edition)

          -  Parents agree to delay initiation of other treatments during double-blind trial

        Exclusion Criteria:

          -  Child has had seizures in past 6 months or a change in seizure medications in past 4
             weeks.

          -  Child has > 18 points on subscale of (Autism Behavior Checklist) ABC-I

          -  Child is taking any psychoactive medication other than supplements, anticonvulsants,
             or soporifics (melatonin, diphenhydramine)

          -  Child has had any change in standing medications in the past 4 weeks.

          -  Child has known genetic disorders

          -  Child has known severe neurological disorders, including cerebral palsy
Ph II Study of Wkly Topotecan + Bevacizumab in Plat. Resistant/Recurrent Gyn Cancers
Condition: Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms
Intervention: Topotecan; Bevacizumab
Intervention description: Topotecan administered days 1, 8, and 15 of each 28 day cycle. Dose was 4 mg/m2 administered IV.; bevacizumab administered IV 10 mg/kg, days 1 and 15 of 28 day cycle.
Intervention MeSH terms: Bevacizumab; Topotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: platinum resistant ovarian cancer; recurrent ovarian cancer; platinum resistant cancer

Summary:

      The purpose of this study is to evaluate the clinical safety and toxicity of intravenous
      bevacizumab (Days 1 and 15 of a 28 day cycle) in combination with weekly topotecan (Days 1,
      8, 15 of a 28 day cycle) in patients with platinum resistant recurrent ovarian, fallopian
      tube and primary peritoneal cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  must have received primary taxane and platinum-based chemotherapy and no more than 1
             other chemotherapy regimen

          -  must have platinum resistant disease(defined as recurrence within 6 months of
             receiving platinum based chemotherapy, first or second line)

          -  must have measurable disease (greater than 20mm by conventional techniques or 10mm by
             spiral CT) OR elevated CA-125 (> 100 on two occasions at least one week apart

          -  performance status greater than or equal to 70%

        Exclusion Criteria:

          -  prior treatment with anti-angiogenesis agent

          -  treatment with > 2 cytotoxic regimens (including primary platinum and taxane
             chemotherapy)

          -  evidence of other malignancy within 3 years of study enrollment

          -  history of abdominal fistula, grade 4 bowel obstruction or gastrointestinal
             perforation

          -  history of intra-abdominal abscess with 6 months prior to day 0

          -  pregnant or lactating patients
Automated Real-time Feedback on CPR Study
Condition: Heart Arrest
MeSH terms: Heart Arrest
Intervention: Laerdal Q-CPR /technology
Intervention description: For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 1586.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate whether or not real-time feedback on CPR process
      variables will increase rates of restoration of spontaneous circulation during prehospital
      resuscitation and upon arrival at the receiving emergency room as well as increase rates of
      survival to hospital discharge.
    

Eligibility criteria:

        Inclusion Criteria:

          -  all individuals who experience cardiac arrest outside the hospital,

          -  are evaluated by organized EMS personnel and: a) receive attempts at external
             defibrillation (by lay responders or emergency personnel) or receive chest
             compressions by organized EMS personnel.

        Exclusion Criteria:

          -  Use of a mechanical CPR device
Cannabidiol Oral Solution for Treatment of Refractory Infantile Spasms
Condition: Spasms, Infantile
MeSH terms: Spasm; Spasms, Infantile
Intervention: Cannabidiol Oral Solution
Intervention description: 20 or 40 mg/kg/day BID
Intervention MeSH terms: Cannabidiol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 6 Months
Maximum age: 36 Months
Healthy volunteers: No

Summary:

      Infantile Spasms (IS) is a diagnosis described as a fairly rare and terrible form of epilepsy
      that usually strikes children in the first year of life. There is a great need for safe and
      effective therapies in the treatment of IS. This need is even more important for infants and
      toddlers still sick after being treated with medicine that is already available.

      This is a multi-center study to evaluate the efficacy and safety of Cannabidiol Oral Solution
      (CBD) in the treatment of children aged 6 months through 36 months with a diagnosis of
      infantile spasms who have not responded to first line therapies.

      The overall study duration is expected to be 64 weeks for those subjects who respond to CBD
      treatment. The maximum possible study duration for each patient is approximately 64 weeks,
      however a subject will be deemed to have completed the study after 58 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets protocol-specified criteria for qualification, including infantile spasms

          -  Parent(s)/caregiver(s) fully comprehend and sign the informed consent form, understand
             all study procedures, and can communicate satisfactorily with the Investigator and
             study coordinator.

        Exclusion Criteria:

          -  History or current use of over-the-counter medications, dietary supplements, or drugs
             outside protocol-specified parameters

          -  Signs, symptoms or history of any condition that, per protocol or in the opinion of
             the investigator, might compromise:

               1. the safety or well-being of the participant or study staff

               2. the analysis of results

          -  During the Safety Treatment and Follow-up Periods, subjects are not to receive the
             following:

               1. any cannabinoids (CBD, Δ9-tetrahydrocannabinol (THC), hemp oil, Realm Oil or
                  marijuana)

               2. any other investigational drug or investigational device
Fluid Chloride and AKI in Cardiopulmonary Bypass
Condition: Acute Kidney Injury
MeSH terms: Acute Kidney Injury
Intervention: 0.9% Normal Saline (0.9% Sodium Chloride) injection; Isolyte S injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Acute kidney injury (AKI) is a potential complication of cardiac surgery. In animal models,
      excess exogenous Cl- ion in the bloodstream is associated with AKI. Normal saline IV fluid
      has higher levels of Cl- ion than the blood usually carries. An alternative IV fluid sold
      under the name Isolyte has lower Cl- ion levels. There is no literature comparing AKI
      outcomes in cardiac patients between patients receiving normal saline vs. Isolyte. The
      investigators propose to recruit and randomize 30 trial-completing cardiac surgery patients
      (up to 40 enrolled) into 2 study arms and compare renal outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Planned on- or off-pump cardiac surgery including: bypass grafting, valvular
             procedures, congenital defect correction, and thoracic aortic procedures or a
             combination of these procedures

        Exclusion Criteria:

          -  Emergency surgery

          -  Pregnancy

          -  Previous renal transplantation

          -  Documented moderate to severe acute kidney injury prior to enrollment (e.g. RIFLE-I or
             RIFLE-F/KDIGO stage 2 or 3)

          -  Patients already receiving dialysis (acute or chronic) or in imminent need of dialysis
             at time of enrollment

          -  Chronic kidney disease without baseline serum creatinine value obtained within 6
             months of enrollment
A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Intervention: Parsaclisib
Intervention description: Parsaclisib tablets administered orally with water and without regard to food.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 162.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Mantle cell lymphoma; non-Hodgkin lymphoma; Bruton's tyrosine kinase (BTK); phosphatidylinositol 3-kinase (PI3K)

Summary:

      This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of
      2 parsaclisib treatment regimens in participants with relapsed or refractory mantle cell
      lymphoma (MCL) previously treated either with or without a Bruton's tyrosine kinase (BTK)
      inhibitor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women, aged 18 years or older.

          -  Documented failure to achieve at least partial response (PR) with, or documented
             disease progression after, the most recent treatment regimen.

          -  Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.

        Exclusion Criteria:

          -  History of central nervous system lymphoma (either primary or metastatic).

          -  Prior treatment with idelalisib, other selective phosphatidylinositol 3-kinase delta
             (PI3Kδ) inhibitors, or a pan PI3K inhibitor.

          -  Allogeneic stem cell transplant within the last 6 months, or autologous stem cell
             transplant within the last 3 months before the date of first dose of study treatment.

          -  Active graft-versus-host disease.

          -  Liver disease: Participants positive for hepatitis B surface antigen or hepatitis B
             core antibody will be eligible if they are negative for hepatitis B
             virus-deoxyribonucleic acid (HBV-DNA). Participants positive for anti-hepatitis C
             virus (HCV) antibody will be eligible if they are negative for HCV-ribonucleic acid
             (RNA).
Study to Evaluate the Efficacy and Safety of Intravenous Infusion With Nemonoxacin Malate Sodium Chloride
Condition: Pneumonia
MeSH terms: Pneumonia
Intervention: Nemonoxacin 500 mg; Nemonoxacin 650 mg; Moxifloxacin 400 mg
Intervention description: IV Infusion, once daily for 7~14 days; IV Infusion, once daily for 7~14 days; IV Infusion, once daily for 7~14 days
Intervention MeSH terms: Moxifloxacin; Nemonoxacin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 207.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Moxifloxacin

Summary:

      The purpose of this study is to Evaluate the Efficacy, safety and pharmacokinetics of
      Intravenous Nemonoxacin Compared with Intravenous Moxifloxacin in Adult Patients with
      community-acquired pneumonia (CAP).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Ages between 18 and 75;

          2. Weighs between 40 ~ 100 kg, and BMI ≥ 18 kg/m2;

          3. Must have a clinical diagnosis of CAP

          4. Chest X-ray and /or CT scan show new or persist/progressive infiltrates

          5. Patients with PORT/PSI score II, III or IV.

          6. If female, non-lactating and at no risk or pregnancy (post-menopausal or must use
             adequate birth control)

          7. The patient is able to receive an intravenous infusion of the drug .

        Exclusion Criteria:

          1. Patients with PORT/PSI score I or VI.

          2. Severe CAP is present if a patient needs invasive mechanical ventilation or requires
             vasopressors.

          3. Known or suspected severe bronchiectasis, cystic fibrosis, active pulmonary
             tuberculosis or infection with other mycobacteria or fungi, known bronchial
             obstruction, a history of post-obstructive pneumonia, other confounding respiratory
             diseases, such as lung cancer, malignancy metastatic to the lungs, lung abscess,
             empyema, suspected aspiration pneumonia due to vomiting, or non-bacterial respiratory
             infection (chronic obstructive pulmonary disease [COPD] is not exclusionary)

          4. Clinically significant conduction or other abnormality on 12-lead ECG, or QTc interval

          5. Potassium is < 3.5 mmol/L

          6. Any known disease that seriously affect the immune system

          7. Active hepatitis or decompensated cirrhosis;

          8. Have used quinolones or fluoroquinolones within 14 days before enrollment

          9. Patients who are being or will be on a long-term medication of steroids
Evaluation of Cold Sore Treatments on Ultra Violet (UV) Induced Cold Sores
Condition: Oral Herpes Simplex
MeSH terms: Herpes Simplex; Herpes Labialis; Stomatitis, Herpetic
Intervention: Matching Placebo; BTL-TML-HSV
Intervention description: Sublingual micro dosing of placebo for 7 days; Sublingual micro dosing of BTL-TML-HSV for 7 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 303.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Herpes Labialis; Herpes Simplex; Herpes; Ultra Violet (UV) Induced

Summary:

      The purpose of this study is to determine if a new drug treatment is effective to block the
      development of a cold sore lesion following Ultra Violet (UV) exposure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical history of recurrent cold sores averaging 2 or more episodes per year

          -  UV exposure is known to cause a cold sore outbreak

        Exclusion Criteria:

          -  History of abnormal reactions to sunlight

          -  Used antiviral therapy directly prior to entering study

          -  Any other condition which in the opinion of the Investigator may affect the results or
             place the subject at undue risk.
OTX-14-006: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Dry Eye
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: Dexamethasone; Placebo Vehicle
Intervention MeSH terms: Dexamethasone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone
      insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the
      treatment of the signs and symptoms of dry eye disease
    

Eligibility criteria:

        Inclusion Criteria:

          -  Had a known history of dry eye disease

          -  Had a minimal Corneal Fluorescein Staining Score and OSDI score in each eye

        Exclusion Criteria:

          -  History of intraocular inflammation in either eye

          -  Use of the anti-inflammatory or immunomodulating agents ocular or systemic for the
             duration of the study

          -  Uncontrolled glaucoma or is on medications to treat glaucoma

          -  History of IOP spikes in either eye

          -  Active epiphora
Safety, Tolerability and Efficacy of ACZ885 on Leg Artery Structure in Patients With Peripheral Artery Disease
Condition: Peripheral Artery Disease
MeSH terms: Peripheral Arterial Disease; Intermittent Claudication
Intervention: Canakinumab (ACZ885); Placebo
Intervention description: Dosage form: solution for injection Strength: 150 mg/1 mL Mode of administration: subcutaneous use.; Matching placebo of Canakinumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Peripheral artery disease; Intermittent claudication; magnetic resonance imaging

Summary:

      This study was designed to assess the safety, tolerability and efficacy of ACZ885 on the leg
      artery structure and physical activity in patients with atherosclerotic peripheral artery
      disease and leg pain from walking.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Must have a signed informed consent form.

          -  Must be between the ages of 18 and 85

          -  Must experience leg pain associated with walking and have an ankle brachial index
             between 0.40 and 0.9

          -  Must be on stable aspirin and statin doses for at least 6 weeks

          -  Blood pressure within ranges specified in the protocol

          -  Able to communicate well with the Investigator and understand and comply with the
             study procedures

        Key Exclusion Criteria:

          -  Recent use of any other experimental drugs

          -  Pregnant or nursing women

          -  Women of child bearing potential unless willing to use contraception as detailed in
             the protocol

          -  Cannot walk 15 meters (50 feet)

          -  People on restricted medications as listed in the protocol

          -  Any open or non-healing wounds with 3 months of study start or infection within 2
             weeks or study start

          -  Significant heart disease

          -  Uncontrolled diabetes

          -  Significant kidney or liver disease

          -  Live vaccinations within 3 months of study start

          -  History of untreated tuberculosis or active tuberculosis (TB)

          -  Patients with metal in their body (excluded due to MRI scan) as detailed in the
             protocol.