bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Tirzepatide; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Tirzepatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the efficacy of tirzepatide in participants with
      type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have type 2 diabetes (T2DM) for ≥6 months according to the Criteria for Diagnosing
             Type 2 Diabetes Mellitus (American Diabetes Association 2017).

          -  Have HbA1c of 7.0% to 10.5%, inclusive, as assessed by the central laboratory.

          -  If on metformin, have been treated with stable doses of metformin for at least 3
             months.

          -  Have a body mass index (BMI) between 23 and 45 (Inclusive) kilograms per square meter.

        Exclusion Criteria:

          -  Have type 1 diabetes (T1D).

          -  Have used any glucose-lowering medication other than metformin within 3 months prior
             to study entry or during screening/lead-in period or have used any glucagon-like
             peptide-1 receptor agonists (GLP-1 RAs) at any time in the past 12 months.

          -  Have had any of the following cardiovascular conditions: acute myocardial infarction
             (MI), New York Heart Association Class III or Class IV heart failure, or
             cerebrovascular accident (stroke).

          -  Have acute or chronic hepatitis, signs and symptoms of any other liver disease other
             than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level
             >2.5 times the upper limit of the reference range, as determined by the central
             laboratory at study entry; participants with NAFLD are eligible for participation in
             this trial.

          -  Have had chronic or acute pancreatitis any time prior to study entry.

          -  Have an estimated glomerular filtration rate (eGFR) <45 milliliters/minute/1.73 square
             meter, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation.

          -  Have serum calcitonin ≥20 picograms per milliliter, as determined by the central
             laboratory at study entry.

          -  Have any condition that is a contraindication for use of the GLP-1 RA class (per
             country-specific labels) at study entry or develop such condition between study entry
             and randomization.
The Role of Contrast Enhanced Ultrasound in Appendicitis
Condition: Acute Appendicitis
MeSH terms: Appendicitis
Intervention: Sulfur hexafluoride lipid-type A microspheres
Intervention description: Contrast Enhanced Ultrasound of the appendix
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: The CEUS image will be read at a future time by a Children's Mercy Hospital radiologist blinded to the results of the gray scale ultrasound and computed tomography (CT) scan if one was obtained; these will be used for comparison.
Enrollment: 37.0
Sex: All
Minimum age: 8 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study seeks to determine the efficacy of Contrast Enhanced Ultrasound (CEUS) in
      improving the diagnosis of acute appendicitis in children, when compared to the standard
      grey-scale ultrasound.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Present to Children's Mercy Adele Hall campus with a clinical concern for acute
             appendicitis

          -  Age 8 through 17 years

          -  seen between Institutional Review Board (IRB) approval date and 12/31/2019

          -  Seen Monday- Friday between the hours of 9:00 a.m. and 4:00 pm

          -  Has had an IV catheter placed as part of their standard of care

        Exclusion Criteria:

          -  Known cardiac abnormality

          -  Pulmonary hypertension

          -  Known sensitivity to sulfur hexafluoride, polyethylene glycol 4000,
             distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium
             (DPPG-Na), or palmitic acid

          -  Does not had an IV catheter placed

          -  Unable to roll over

          -  Unable to assent

          -  Pregnant

          -  Lactating

          -  Received an ultrasound image from a referring facility
Safety and Efficacy of USB002 for Respiratory Distress Due to COVID-19
Condition: 2019 Novel Coronavirus Infection; COVID-19 Virus Infection; SARS Coronavirus 2 Infection; SARS-CoV-2 Infection; Respiratory Distress Syndrome, Adult; Adult Respiratory Distress Syndrome
MeSH terms: Infections; Communicable Diseases; COVID-19; Coronavirus Infections; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Intervention: USB002; Placebo
Intervention description: USB002 is pharmaceutically formulated Angiotensin 1-7 [A(1-7)], a non-hypertensive derivative of Angiotensin-II (A-II), and is suspended in a vehicle as a sterile solution of USB002. Depending upon cohort assignment, subjects in the USB002 group will receive one of four doses of USB002 administered intravenously (IV).; The placebo formulation will be the USB002 formulated solution without the addition of A(1-7). The placebo will be administered intravenously (IV).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial will study the use of USB002 given as an intravenous infusion in patients with
      respiratory distress due to infection with COVID-19.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed informed consent from patient or legal representative;

          2. Age 18 or greater;

          3. Positive reverse transcription polymerase chain reaction (RT-PCR) for SARS-CoV-2 (≤10
             days);

          4. Respiratory rate > 20 RR;

          5. SpO2 < 94% on room air, requiring supplemental oxygen, requiring invasive mechanical
             ventilation, or requiring ECMO;

          6. Chest X-ray confirming bilateral pulmonary infiltrates;

          7. Body mass index of ≤ 40 units/kg/m2;

          8. Adequate method of birth control.

        Exclusion Criteria:

          1. Terminally ill patients due to underlying cardiac, cancer or severe debilitating
             neurological disease including coma;

          2. Hospitalization expected to be < 96 hours due to medical improvement;

          3. Interstitial lung disease;

          4. Correction of QTc values obtained by 12 lead EKG using Fredericia's formula (QTcF) >
             450 ms;

          5. History of hypotension (mean arterial blood pressure < 65 mmHg), unrelated to CoVID-19
             infection;

          6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times upper
             limit of normal;

          7. Participating concurrently on another clinical trial for the experimental treatment of
             COVID-19;

          8. Active chemotherapy use;

          9. Pregnant and/or lactating women.
Naltrexone and Memantine Effects on Alcohol Drinking Behaviors
Condition: Alcohol Drinking
MeSH terms: Alcohol Drinking; Drinking Behavior
Intervention: Naltrexone and memantine first; Naltrexone and Placebo first
Intervention description: Naltrexone 50mg memantine 20mg; Naltrexone 50 mg Placebo
Intervention MeSH terms: Naltrexone; Memantine
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 75.0
Sex: All
Minimum age: 21 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Alcohol; Drinking; Drinkers; Alcohol Drinking; Memantine; Naltrexone; Alcohol Dependence; Alcohol Abuse; Alcohol-Related Disorders; Ethanol; Alcoholism

Summary:

      The purpose of this study is to evaluate the combined effects of the study medications
      naltrexone and memantine on alcohol drinking behaviors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 21-55

          -  Able to read English at 6th grade level or higher and to complete study evaluations

          -  Regular alcohol drinker

        Exclusion Criteria:

          -  Individuals who are seeking alcohol treatment

          -  Medical conditions that would contraindicate the use of study medication

          -  Regular use of other substances
Prevention of Clostridium Difficile-associated Diarrhea by Daily Intake of Kefir
Condition: Clostridium Difficile Infection; Diarrhea
MeSH terms: Clostridium Infections; Diarrhea
Intervention: kefir
Intervention description: 4 ounces of kefir 3 times a day, with or without food.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      This study is being conducted to investigate the potential benefits of probiotic intake for
      preventing antibiotic associated diarrhea and Clostridium difficile infection in patients
      undergoing a systemic antibiotic treatment. The primary research question is: can daily
      intake of kefir, a yogurt-like food containing probiotics, reduce the incidence of diarrhea
      and Clostridium difficile infection in patients during antibiotic treatment?
    

Eligibility criteria:

        Inclusion Criteria:

        Patients who have:

          -  Been admitted to the medical unit on 7 West at St. Luke's Hospital (Duluth, MN)

          -  Been prescribed a systemic antibiotic of any kind (administered by oral or parenteral
             route), but have not yet started the regimen

          -  Consented to be randomized and take part in the study and are adults greater than 19
             years of age

        Exclusion Criteria:

        Patients who are/have:

          -  Tube feeding

          -  Undergoing dialysis and other renal treatment

          -  An existing C. difficile infection

          -  A recent history of C. difficile infection (within the last 3 months)

          -  A recent history of antibiotic use (within the last 3 months)

          -  Inflammatory bowel disease, Crohn's disease, or other chronic gastrointestinal
             syndrome

          -  A history of acquired of genetic immunodeficiencies; active, acute or chronic serious
             infections (i.e., viral hepatitis, HIV/AIDS), or autoimmune disorders

          -  Undergoing gastrointestinal surgery, radiation, or cytotoxic chemotherapy

          -  Allergy to milk protein
Phase 2 Study of AKCEA-ANGPTL3-LRx (ISIS 703802) in Participants With Familial Chylomicronemia Syndrome (FCS)
Condition: Familial Chylomicronemia Syndrome; Lipoprotein Lipase Deficiency; Hyperlipoproteinemia Type 1
MeSH terms: Hyperlipoproteinemia Type I; Hyperlipoproteinemias; Hyperlipidemias; Syndrome
Intervention: AKCEA-ANGPTL3-LRx
Intervention description: AKCEA-ANGPTL3-LRx at dose 20 mg, administered via SC injection QW.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Familial Lipoprotein Lipase Deficiency; Hyperlipoproteinemias; Familial Hyperlipoproteinemia Type 1; Hyperlipoproteinemia Type I; Hyperchylomicronemia, Familial; Lipoprotein Lipase Deficiency, Familial; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Lipid Metabolism, Inborn Errors; Metabolic Diseases; Metabolism, Inborn Errors; Genetic Diseases, Inborn

Summary:

      This is a single center, open-label study to evaluate the efficacy of AKCEA-ANGPTL3-LRx for
      reduction of triglyceride (TG) levels in participants with FCS.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Genetically confirmed chylomicronemia syndrome.

          -  Fasting triglycerides greater than or equal to (>=) 750 milligrams per deciliter
             (mg/dL) [8.4 millimoles per liter (mmol/L)] at Screening.

        Key Exclusion Criteria:

          -  Diabetes mellitus if newly diagnosed or if glycated hemoglobin (HbA1c) >= 9.0%.

          -  Active pancreatitis within 2 weeks of screening.

          -  Acute coronary syndrome within 6 months of screening.

          -  Major surgery within 3 months of screening.

          -  Treatment with Glybera therapy within 2 years of screening.

          -  Previous treatment with AKCEA-ANGPTL3-LRx.

          -  Have any other conditions in the opinion of the investigator which could interfere
             with the patient participating in or completing the study.
Study of CDI-31244 in Combination With Sofosbuvir (SOF) and Velpatasvir (VEL)
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: CDI-31244; SOF/VEL
Intervention description: investigational drug; sofosbuvir and velpatasvir fixed dose combination
Intervention MeSH terms: Sofosbuvir-velpatasvir drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HCV; GT1

Summary:

      Open label phase 2a study of two week treatment with CDI-31244 and sofosbuvir and veltapasvir
      followed by four week treatment of sofosbuvir and velpatasvir in individuals with chronic
      hepatitis C (HCV) genotype 1 (GT1) infection
    

Eligibility criteria:

        Key Inclusion Criteria:

        Documented chronic HCV GT 1 infection; Serum HCV RNA >1,000 IU/mL during screening; Absence
        of advanced fibrosis or cirrhosis

        Key Exclusion Criteria:

        Nursing or pregnant women; Active hepatitis B infection; Human immunodeficiency virus (HIV)
        infection; History of use of any HCV direct-acting antiviral therapy
Riluzole Augmentation Pilot in Depression (RAPID) Trial
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: Riluzole; Sertraline; placebo
Intervention MeSH terms: Riluzole; Sertraline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Major Depression; Major Depressive Disorder; Depression; Riluzole; Glutamate; Sertraline

Summary:

      The investigators are doing a research study to find out if riluzole, when taken along with a
      standard antidepressant (sertraline) can help people with major depression.

      This research study will compare riluzole + sertraline to placebo + sertraline. The
      investigators hypothesize that adding riluzole will lead to a better antidepressant response,
      in less time, then sertraline alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults (ages 18-75) who meet DSM-IV criteria for a major depressive episode,

          -  Hamilton Depression Rating Scale (HDRS) >22, and

          -  No antidepressant treatment for at least three weeks

        Exclusion Criteria:

          -  Active drug or alcohol disorder in the past 3 months

          -  History of psychosis, history of mania or hypomania

          -  Epilepsy or history of seizures

          -  Hypothyroidism

          -  Congenital QTc prolongation

          -  Liver disease

          -  Lung disease

          -  Acute suicide or homicide risk

          -  Pregnant women, breastfeeding women, women of childbearing age not using contraception

          -  Unstable medical illness

          -  Elevated thyroid-stimulating hormone (TSH>5.0mlU/L), or

          -  Abnormal liver function tests (ALT>50 U/L or AST>50 U/L)

          -  ADD / ADHD (Attention deficit hyperactivity disorder)

        Disallowed therapies include: other psychotropic medications, including antipsychotics,
        mood stabilizers, benzodiazepines, barbiturates, other sedative-hypnotics, chronic opiates,
        or additional antidepressants, psychotherapy, electroconvulsive therapy, vagal nerve
        stimulations therapy, transcranial magnetic stimulation therapy, or phototherapy.
A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Baricitinib; Placebo
Intervention description: Administered orally; Administered orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 314.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate the efficacy and safety of the study drug known
      as baricitinib in participants with systemic lupus erythematosus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have received a diagnosis of SLE at least 24 weeks prior to screening, meeting the
             American College of Rheumatology (ACR) 1982 revised criteria OR the 2012 Systemic
             Lupus Erythematosus International Collaborating Clinics (SLICC) criteria.

          -  Have a positive antinuclear antibody (ANA) (titer ≥1:80) and/or a positive
             anti-double-stranded deoxyribonucleic acid (dsDNA) as assessed by a central laboratory
             at screening.

          -  Have a SLEDAI-2K score ≥4 based on clinical symptoms (not including lab values) at
             randomization.

          -  Have active arthritis and/or active rash as defined by the SLEDAI-2K at randomization.

        Exclusion Criteria:

          -  Have active severe lupus nephritis.

          -  Have active severe central nervous system (CNS) lupus.

          -  Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal,
             endocrine, hematological, neurological, or neuropsychiatric disorders or any other
             serious and/or unstable illness that, in the opinion of the investigator, could
             constitute an unacceptable risk when taking investigational product or interfere with
             the interpretation of data.

          -  Have a current or recent clinically serious viral, bacterial, fungal, or parasitic
             infection.

          -  Are currently receiving oral corticosteroids at doses >20-milligrams per day of
             prednisone (or equivalent) or have adjusted the dose of corticosteroids within 2 weeks
             of planned randomization.

          -  Have started treatment with or adjusted the dose of nonsteroidal anti-inflammatory
             drugs (NSAIDs) (for which the NSAID use is intended for treatment of signs and
             symptoms of SLE) within 4 weeks of planned randomization.

          -  Have started treatment with or adjusted the dose of an antimalarial within 12 weeks of
             planned randomization.

          -  Have started treatment with or adjusted the dose of an immunosuppressant within 12
             weeks of planned randomization.

          -  Have received cyclophosphamide (or any other cytotoxic agent) within 12 weeks prior to
             screening.
A Study of ATI-50002 Topical Solution for the Treatment of Alopecia Areata
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Intervention: ATI-50002 high dose; ATI-50002 low dose; Placebo
Intervention description: Topical solution; Topical solution; Topical solution
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 129.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      Primary:

      • To assess safety, tolerability and efficacy of 2 dose strengths of ATI-50002 Topical
      Solution, compared to vehicle in subjects with alopecia areata (AA)

      Secondary:

      • To evaluate key clinical outcome assessments
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have a clinical diagnosis of stable patchy alopecia areata (AA) defined as no current
             areas of spontaneous regrowth.

          2. Have a Severity of Alopecia Tool (SALT) score of at least 15% up to 95% total scalp
             hair loss determined by the study investigator at baseline.

          3. Have a duration of the current episode of scalp hair loss of a minimum of 6 months and
             a maximum of 12 years.

          4. If a woman of childbearing potential (WOCBP), must have a negative serum pregnancy
             test at Screening (Visit 1) and a negative urine pregnancy test at Baseline (Visit 2)
             and agree to: use a highly effective method of birth control for the duration of the
             study; not be planning a pregnancy during the study duration and use contraception for
             30 days after last application of study medication.

        Exclusion Criteria:

          1. Females who are nursing, pregnant, or planning to become pregnant for the duration of
             the study and up to 30 days after the last application of study medication.

          2. Diffuse alopecia areata.

          3. Concomitant hair loss disorder (by history or physical exam) such as androgenetic
             alopecia or scarring alopecia (e.g., cicatricial alopecia, frontal fibrosing alopecia,
             etc.).

          4. Active skin disease on the scalp (such as psoriasis or seborrheic dermatitis) or a
             history of skin disease on the scalp that in the opinion of the investigator would
             interfere with the study assessments of efficacy or safety.

          5. Active scalp trauma or other condition affecting the scalp that, in the investigator's
             opinion, may affect the course of AA or interfere with the study conduct or
             evaluations.

          6. The presence of a permanent or difficult to remove hairpiece or wig that will, in the
             opinion of the investigator, interfere with study assessments if not removed at each
             visit.