bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Tolerability, Pharmacokinetics and Efficacy of EYP001a in Patients With Nonalcoholic Steatohepatitis (NASH)
Condition: Non-alcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: Vonafexor; Placebo
Intervention description: Oral tablets; Oral tablets
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Triple (Participant, Care Provider, Investigator)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: EYP001 (vonafexor); Liver Diseases; Non-alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis; NASH

Summary:

      The purpose of this study is to assess the effects of EYP001a (Vonafexor) with respect to
      safety, tolerability, pharmacokinetics and on markers of liver inflammation in patients with
      NASH
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent

          -  Suspected diagnosis of NASH, evidenced by elevated alanine aminotransferase (ALT),
             liver stiffness compatible with F2 or F3 fibrosis and Liver Fat Content (LFC) ≥10% as
             measured by MRI

          -  Women of childbearing potential and male patients with female partners must agree to
             use a dual method of contraception

        Exclusion Criteria:

          -  Evidence of worsening liver injury

          -  Previous diagnosis of other forms of non-NASH liver disease

          -  Use of Vitamin E, glitazones, glucagon-like Peptide-1 receptor agonists,
             ursodeoxycholic acid, or obeticholic acid within 90 days prior to screening

          -  History of cirrhosis or liver decompensation

          -  Known history of alcohol abuse or daily heavy alcohol consumption

          -  Pregnant or breastfeeding women

          -  Type 1 diabetes mellitus and uncontrolled type 2 diabetes mellitus

          -  Patients with contraindications to MRI imaging
Inhaled GM-CSF Therapy of Autoimmune PAP
Condition: Autoimmune Pulmonary Alveolar Proteinosis
MeSH terms: Pulmonary Alveolar Proteinosis
Intervention: Baseline WLL; Sargramostim; Rescue WLL
Intervention description: Scheduled bilateral WLL; Inhaled GM-CSF; Unscheduled bilateral WLL
Intervention MeSH terms: Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Whole lung lavage; GM-CSF; Sargramostim; aPAP

Summary:

      This is a prospective, randomized, open-label, long-term, phase 2 study of inhaled
      granulocyte/macrophage-colony stimulating factor following whole lung lavage therapy in
      patients with autoimmune pulmonary alveolar proteinosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female of male 18 years of age or older

          -  Diagnosis of autoimmune PAP

          -  Able and willing to provide written informed consent

          -  Eligible for whole lung lavage determined as the presence of persistent or progressive
             respiratory failure (PaO2 at rest < 60 mm Hg) or desaturation < 90% or > 5 percentage
             points during standard exercise

        Exclusion Criteria:

          -  Diagnosis with secondary PAP, congenital PAP, or hereditary PAP

          -  Contraindication to whole lung lavage

          -  Contraindication to administration of inhaled GM-CSF

          -  Chronic lung disease associated with already existing respiratory failure, such as
             emphysema or pulmonary fibrosis, chronic heart failure, ischemic heart disease, active
             pulmonary embolism, progressive cancer, and other severe metabolic conditions
Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Intermittent Explosive Disorder
Condition: Intermittent Explosive Disorder
MeSH terms: Disruptive, Impulse Control, and Conduct Disorders
Intervention: AVP-786; Placebo
Intervention description: oral capsules; oral capsules
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Intermittent Explosive Disorder; AVP-786

Summary:

      This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate AVP-786
      for the treatment of Intermittent Explosive Disorder (IED).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of current Intermittent Explosive Disorder (IED) according to the Diagnostic
             and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria, as solicited
             by the Structured Clinical Interview for DSM-5, Clinical Trials Version

          -  At least 3 IED days (at least 1 IED episode each day, as recorded by the participant)
             per week for the 2 consecutive weeks directly preceding baseline with 70% compliance
             during that time frame, as assessed by the investigator

          -  Score ≥ 12 on the Life History of Aggression scale at screening

          -  Score ≥ 6 on the Overt Aggression Scale - Modified Total Irritability at screening and
             baseline

          -  Score ≥ 4 on the modified Clinical Global Impression of Severity for IED at screening
             and baseline

        Exclusion Criteria:

          -  Diagnosis of major depressive disorder within 6 months of screening

          -  Significant symptoms of a depressive disorder or a Patient Health Questionnaire-9
             score ≥ 10 at screening

          -  Met only the DSM-5 A2 criterion for IED

          -  Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder,
             antisocial personality disorder, neurocognitive disorder, or mental retardation (DSM-5
             criteria)

          -  Recurrent IED episodes that are better explained by another mental disorder or
             attributable to another medical condition (e.g., head trauma, Alzheimer's disease) or
             to the physiological effect of a substance (e.g., a drug of abuse, a medication)
             (DSM-5 criteria)
Consultation, Advice, and Tailored Support (CATS) for Cancer Survivors
Condition: Smoking Cessation; Social Stress
Intervention: Social Support; NRT Sampling
Intervention description: A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail.; A brief phone consult (10-15 minutes via phone) germane to smoking cessation akin to "brief advice", a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and a free, 2-week supply of nicotine patches and lozenges delivered via mail.
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The objectives of this pilot clinical trial are: 1) To evaluate the feasibility and
      acceptability of a new approach to smoking cessation induction treatment in cancer survivors
      with low social resources, and 2) To assess the effectiveness of said treatment for key
      events in the process of smoking cessation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cervical or head/neck cancer diagnosis in the past 5 years

          -  Resident of rural and/or Appalachian Kentucky county at cancer diagnosis

          -  Current smoker of ≥ 10 cigarettes per day, on average

          -  Age 18-75 years old

          -  Able to read, write, and understand English

        Exclusion Criteria:

          -  Unreliable phone access

          -  Smoking cessation treatment use in past 30 days

          -  Non-cigarette tobacco use in the past 30 days

          -  Any FDA contraindication for NRT use, including: allergy to nicotine patches and/or
             nicotine lozenges; severe kidney or liver disease; unstable angina or serious
             arrhythmia; epilepsy or seizure disorder; myocardial infarction in the past 3 months

          -  Cognitive or psychiatric disorder that would interfere with ability to provide
             informed consent or answer survey questions reliably *

             * Any of these Diagnostic and Statistical Manual-5 (DSM-5) cognitive and psychiatric
             disorders would make someone ineligible: bipolar; delusional; dissociative;
             intellectual developmental; neurocognitive; psychotic; schizophreniform,
             schizophrenia, and schizoaffective.

          -  For women: breastfeeding, pregnancy, or plan to become pregnant within 6 months

          -  For women of childbearing potential: unwillingness to use an effective method of birth
             control (e.g., abstinence, oral contraceptive) while in this study
Study Evaluating the Safety and Tolerability of NCX 4251 for the Treatment of Acute Exacerbations of Blepharitis
Condition: Blepharitis
MeSH terms: Blepharitis
Intervention: Fluticasone Propionate; Placebo
Intervention description: NCX 4251 Ophthalmic Suspension, 0.1%; NCX 4251 Ophthalmic Suspension, 0%
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: sequential dose-escalating cohorts -- Cohort 1 (2 parallel groups) and Cohort 2 (2 parallel groups)
Masking: Double (Participant, Investigator)
Masking description: double-masked
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multi-center, randomized, double-masked, placebo-controlled, Phase 2 study
      evaluating the safety and tolerability of NCX 4251 (fluticasone propionate nanocrystal)
      Ophthalmic Suspension 0.1% QD and BID for the treatment of acute exacerbations of
      blepharitis. The study will be performed in two sequential dose escalating cohorts.

      The study is designed to select the dose(s) of NCX 4251 to advance into the next stage of
      development, and to assess the safety and tolerability of NCX 4251 Ophthalmic Suspension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  history of blepharitis and meet qualifying criteria for an acute exacerbation of
             blepharitis in both eyes at Screening and Baseline/Day 1 Visits

          -  have a qualifying best-corrected visual acuity

        Exclusion Criteria:

          -  abnormality of the eyelids or lashes (other than blepharitis), or previous eyelid
             surgery

          -  IOP > 21 mmHg at Screening or Baseline/Day 1 Visits

          -  use of steroids in the past 30 days or retinoids in the past 12 months

          -  uncontrolled systemic disease
The Efficacy and Safety Study of Tung's Acupuncture for Polycystic Ovarian Syndrome
Condition: Polycystic Ovarian Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Intervention: Tung's acupuncture; Cyproterone acetate/ethinylestradiol (CPA/EE)
Intervention description: The study took Tung's acupoints as main acupuncture points, which were Fuke, Huanchao, Tianhuang, Renhuang, as well as the traditional acupoints Guanyuan (CV4) and Zigong (EX-CA1).; Cyproterone acetate/ethinylestradiol (CPA/EE) contains 2mg cyproterone acetate (an anti-androgenic progestin) and 0.035mg ethinylestradiol (CPA/EE). The pills were administered for 21 days consecutively. The patients then stopped taking the pills for seven days and, on the eighth day, continued to take the pills again for three menstrual cycles (28 day cycles).
Intervention MeSH terms: Cyproterone Acetate; Ethinyl Estradiol; Cyproterone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study was a randomized, drug-controlled, and parallel group trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: acupuncture; LH/FSH; total testosterone (TT); polycystic ovarian syndrome(PCOS)

Summary:

      This study evaluates the efficacy and safety in improving ovarian function of polycystic
      ovarian syndrome in adults. Half of patients will receive Tung's acupuncture therapy, while
      the other half will receive Diane-35(CPA/EE) as the control group.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Chinese;

          2. 18-45 years old;

          3. to meet the diagnostic criteria for polycystic ovary syndrome;

          4. no need for pregnancy in the next six months;

          5. volunteering to join this research and give informed consent prior to receiving
             treatment.

        Exclusion Criteria:

          1. hypertensive patients with blood pressure exceed 160/100 mmHg;

          2. a history of thrombosis,cerebrolvascular diseases, cancer, liver disease or liver
             dysfuction, hyperlipidemia, mental disorder, and severe infection;

          3. having taken any pharmacological treatments affecting reproductive endocrine system;

          4. having received acupuncture in the previous three months;

          5. smoking more than 15 cigarettes per day;

          6. having pacemakers, metal allergies or severe fear of acupuncture.
Omega-3 Fatty Acids in Adolescent Depression
Condition: Adolescent Depression
MeSH terms: Depression; Depressive Disorder
Intervention: Omega-3 Fatty Acids; corn oil
Intervention description: 10 wk treatment period; placebo comparator
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 57.0
Sex: All
Minimum age: 12 Years
Maximum age: 19 Years
Healthy volunteers: No
Keywords: Adolescents; Depression; Fish Oil; Omega-3 Fatty Acids; Psychiatry

Summary:

      Aim. To provide preliminary data about the efficacy of omega-3FA in the treatment of
      adolescent MDD. To address this aim, a 10-week double blind, placebo-controlled study of
      omega-3FA, using a flexible dose titration is proposed. Primary outcome measures will be: (1)
      change in the total score of the Children's Depression Rating Scale-Revised (CDRS-R) at the
      end of treatment (2) response rate on the Clinical Global Improvement scale (CGI) at the end
      of 10-week treatment.

      Hypothesis. Omega-3FA treatment in adolescents with MDD will result in a significant
      reduction of CDRS-R total scores, and a significantly higher improvement rate on the CGI at
      the end of treatment compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: 12-19

          -  Depressed with DSM-IV diagnosis of MDD

          -  Duration of depressive episode greater than 6 weeks

        Exclusion Criteria:

          -  Current or past DSM-IV-TR bipolar, schizophrenia, psychosis, pervasive developmental
             disorder (PDD), and Tourette's disorder.

          -  Current diagnosis of eating, panic, conduct, obsessive compulsive, post traumatic
             stress, and/or substance-related disorders (other than nicotine).

          -  Adolescents who present with current suicidal ideation with intent or plan, or who may
             pose a danger to themselves.

          -  Current antidepressant treatment, or taken within 60 days prior to enrollment

          -  Neuroleptics taken within 90 days prior to enrollment
Colchicine to Reduce Cardiac Injury in COVID-19 (COLHEART-19)
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Colchicine Tablets; Current care per UCLA treating physicians
Intervention description: COLCRYS (colchicine, USP) tablets for oral administration, containing 0.6 mg of the active ingredient colchicine USP, administered po every 12 hours x 30 days.; Current care
Intervention MeSH terms: Colchicine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Random assignment to study arms in a 1:1 ratio
Masking: None (Open Label)
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Participants will be randomized in a 1:1 ratio to receive Colchicine plus current care per
      UCLA treating physicians versus current care per UCLA treating physicians alone (control
      arm). Importantly, this adaptive trial design allows for patients in either study arm to
      receive other investigational drugs for COVID-19 as new science emerges.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed COVID-19 infection by polymerase chain reaction

          -  Cardiac injury, including any of the following:

               -  Elevated troponin level

               -  Elevated B-type natriuretic peptide (BNP) level

               -  New ischemic or arrhythmogenic changes on ECG/telemetry

               -  New decrease in left ventricular ejection fraction (LVEF) or new pericardial
                  effusion on echocardiogram

          -  Able to provide informed consent

        Exclusion Criteria:

          -  Pregnancy, breastfeeding mothers, and women of childbearing age who are unable to use
             2 forms of contraception, which includes:

               -  Intrauterine devices (IUD), contraceptive implants, or tubal sterilization

               -  Hormone methods with a barrier method

               -  Two barrier methods

               -  If a partner's vasectomy is the chosen method of contraception, a hormone or
                  barrier method must also be used in conjunction

          -  Co-administration of Cytochrome P450 3A4 (CYPA3A4) and P-glycoprotein (P-gp) transport
             system inhibitors

          -  Concurrent use of strong CYP3A4 or P-gp inhibitors in patients with renal or hepatic
             impairment;

          -  Severe hematologic or neuromuscular disorders

          -  Severe renal impairment with concomitant hepatic impairment
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg, Ezetimibe 10mg, and Atorvastatin 20 mg Triplet Therapy in Patients With Elevated LDL-C
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Bempedoic acid 180mg; Ezetimibe 10mg; Atorvastatin 20mg; Placebo
Intervention description: bempedoic acid 180 mg; ezetimibe 10 mg; atorvastatin 20 mg; placebo
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid; Atorvastatin; Ezetimibe
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hyperlididemia; LDL; cholesterol

Summary:

      The purpose of this study is to determine if triplet therapy with bempedoic acid (ETC-1002)
      180mg, ezetimibe 10mg, and atorvastatin 20mg is effective and safe versus placebo in patients
      with elevated LDL cholesterol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Fasting LDL-cholesterol between 130 - 189 mg/dL at screening following washout of all
             LDL-C-lowering drugs and nutritional supplements

          -  Men and nonpregnant, nonlactating women

          -  Sufficiently stable and suitable to undergo washout of all LDL-C-lowering drugs and
             nutritional supplements for 12 weeks

        Exclusion Criteria:

          -  Fasting blood triglycerides greater than or equal to 400 mg/dL

          -  Body Mass Index (BMI) greater than 50 kg/m2

          -  History of clinically significant cardiovascular disease

          -  History of type 1 or type 2 diabetes
HEROIC (Heparin Requirement in Counterpulsation)
Condition: Cardiogenic Shock
MeSH terms: Shock, Cardiogenic
Intervention: Heparin; Without Heparin
Intervention description: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP).; Intra-Aortic balloon Pump (IABP) without Heparin.
Intervention MeSH terms: Heparin; Calcium heparin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Intraaortic balloon pumping; Heparin; Limb ischemia; Bleeding

Summary:

      Patients with intra-aortic balloon pumps (catheters placed in the groin connected to a pump
      which assists the heart by opening and closing a balloon in the aorta, thereby decreasing the
      work of the heart and improving blood flow to the coronary arteries) often receive
      intravenous (IV) heparin (a "blood thinner") to prevent circulation problems in the leg
      (where they are inserted). When intra-aortic balloon pumps were initially developed, the
      catheters were larger than the catheters used today. Due to the large size of the catheter
      and the material used to make the catheter, it was thought that intravenous heparin would
      prevent poor blood flow to the leg that contained the temporary catheter. Intravenous
      heparin, however, has never been proven to maintain good blood flow in these patients. The
      catheters used with intra-aortic balloon pumps are now smaller in size and made of a material
      that is less likely to produce blood clots. It is not clear that heparin is needed with
      intra-aortic balloon pumps. Bleeding complications associated with intra-aortic balloon pumps
      may be decreased if heparin is not used. In 2004, 99 patients received intra-aortic balloon
      pumps in the cardiac catheterization labs at William Beaumont Hospital. These patients
      received intravenous heparin and experienced a large number of bleeding complications (27
      patients required a blood transfusion). This study will help the investigators to clarify if
      heparin should or should not be routinely used in patients with intra-aortic balloon pumps.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >/= 18 years

          -  Able to provide consent

          -  Insertion of Intra-aortic Balloon Pump (IABP) in William Beaumont Hospital (WBH) cath
             lab

          -  Anticipated duration of IABP >/= 18 hours

        Exclusion Criteria:

          -  Contraindications to heparin

          -  Pre-existing condition requiring heparin administration (other than IABP)

          -  IABP placed outside of the WBH cardiac catheterization lab prophylactically for
             high-risk percutaneous coronary intervention (PCI), without complications)

          -  Pregnant women