bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Mirikizumab; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Mirikizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 205.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: IL-23; dermatology

Summary:

      The main purpose of this study is to evaluate the efficacy of the study drug mirikizumab in
      participants with moderate to severe plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Present with chronic plaque psoriasis based on an investigator confirmed diagnosis of
             chronic psoriasis vulgaris for at least 6 months prior to baseline and meet the
             following criteria:

               -  plaque psoriasis involving ≥10% body surface area (BSA) and absolute PASI score
                  ≥12 in affected skin at screening and baseline

               -  sPGA score of ≥3 at screening and baseline

          -  Candidate for biologic treatment for psoriasis.

        Exclusion Criteria:

          -  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 a risk when taking investigational product or could interfere with the
             interpretation of data.

          -  Breastfeeding or nursing (lactating) women.

          -  Have had serious, opportunistic, or chronic/recurring infection within 6 months prior
             to screening.

          -  Have received live vaccine(s) (included attenuated live vaccines) within 1 month of
             screening or intend to during the study.

          -  Have any other skin conditions (excluding psoriasis) that would affect interpretation
             of the results.

          -  Have received systemic nonbiologic psoriasis therapy or phototherapy within 28 days
             prior to baseline.

          -  Have received topical psoriasis treatment within 14 days prior to baseline.

          -  Have received anti-tumor necrosis factor (TNF) biologics, or anti-interleukin (IL)-17
             targeting biologics within 8 weeks prior to baseline.

          -  Have previous exposure to any biologic therapy targeting IL-23 (including
             ustekinumab), either licensed or investigational (previous briakinumab use is
             permitted).
Study of the Efficacy and Safety of MEDI4893
Condition: Staphylococcus Aureus Pneumonia
MeSH terms: Pneumonia, Staphylococcal
Intervention: MEDI4893; Placebo
Intervention description: Participants will receive a single IV dose of MEDI4893 2000 or 5000 mg on Day 1 of the study.; Participants will receive a single IV dose of placebo matched to MEDI4893 on Day 1 of the study.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 213.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No

Summary:

      Clinical trial looking at safety and efficacy of MEDI4893 in prevention of pneumonia caused
      by Staphylococcus aureus in high-risk patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  Colonized with Staphylococcus aureus, expected to require prolonged intubation and
             mechanical ventilation, without any evidence of active pneumonia.

        Exclusion Criteria:

          -  Staphylococcal disease at randomisation; lung injury score consistent with pneumonia;
             current lung disease; chronic tracheostomy patients; currently receiving systemic
             anti-staphylococcal antibiotics; moribund patients.
A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Vitiligo
Condition: NonSegmental Vitiligo
MeSH terms: Vitiligo
Intervention: INCB054707; Placebo
Intervention description: INCB054707 will be administered once daily; Placebo or INCB054707 will be administered once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Double blinded
Enrollment: 171.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of INCB054707 over a 24-week
      placebo-controlled double-blind treatment period, followed by a 28-week double-blind
      extension period in participants with nonsegmental vitiligo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of nonsegmental vitiligo.

          -  History of prior vitiligo treatment with a total duration of at least 3 months.

          -  Agreement to discontinue all agents and procedures used to treat vitiligo from
             screening through the final safety follow-up visit.

          -  Willingness to avoid pregnancy or fathering children

          -  Further inclusion criteria apply.

        Exclusion Criteria:

          -  Other forms of vitiligo (eg, segmental) or other skin depigmentation disorders.

          -  Uncontrolled thyroid function at screening as determined by the investigator.

          -  Women who are pregnant (or who are considering pregnancy) or lactating.

          -  Medical history including thrombocytopenia, coagulopathy or platelet dysfunction,
             Q-wave interval abnormalities, current or history of certain infections, cancer,
             lymphoproliferative disorders and other medical conditions at the discretion of the
             investigator.

          -  Have evidence of active or latent or inadequately treated infection with Mycobacterium
             tuberculosis.

          -  Participants known to be infected with HIV, Hepatitis B, or Hepatitis C.

          -  Laboratory values outside of the protocol-defined ranges.

          -  Further exclusion criteria apply.
Efficacy and Safety Study of CD2027 Ointment 3 Microgram Per Gram (mcg/g) Twice Daily Treatment for Adults With at Least Moderate Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: CD2027 Ointment 3 mcg/g, twice daily; Vehicle Ointment, twice daily
Intervention description: Topical Ointment; Topical Ointment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dermatitis, Atopic

Summary:

      This was a multi-center, randomized, double-blind, parallel group study. Efficacy Objectives:
      To evaluate the efficacy of CD2027 ointment 3 mcg/g applied twice daily over 4 weeks versus
      its vehicle in adult participants with at least moderate atopic dermatitis.

      Safety objective: To evaluate safety of CD2027 ointment 3 mcg/g when applied twice daily over
      4 weeks versus its vehicle on 5 percent (%) - 20% involved Body Surface Area (BSA) (excluding
      Head/Neck) in adult participants with at least moderate atopic dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participant, 18 years of age or older

          -  Clinical diagnosis of atopic dermatitis according to Hanifin and Rajka criteria, of at
             least moderate intensity according to Investigator Global Assessment (IGA greater or
             equal to 3)

          -  Body surface affected by the disease between 5% and 20% of total BSA, based on Rule of
             Nine's, excluding Head/Neck

          -  At least one area (Target Lesion) which was representative of the participant's
             disease state, was not located on the hands, feet or genitalia, measures at least 10
             cm^2, presented a Total Severity Score of at least 6/15 (total severity score defined
             as the sum of Erythema, Excoriation, Papulation/Induration, Oozing/Crusting and
             Lichenification) with oozing/crusting severity at most 1

        Exclusion Criteria:

          -  The participant had albumin-adjusted calcium above the upper normal range from
             screening evaluation

          -  The participant had history/signs/symptoms suggestive of an abnormality of calcium
             homeostasis (such as hyperparathyroidism, Paget's disease, adrenal insufficiency,
             hyperthyroidism)

          -  The participant had signs/symptoms of urinary stones or has a history of urinary
             stones within the past 5 years prior to the Screening Visit
Study of Coagulation Factor VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia A and B
Condition: Hemophilia A With Inhibitor; Hemophilia B With Inhibitor
MeSH terms: Hemophilia A; Hemophilia B
Intervention: Coagulation Factor VIIa variant
Intervention description: Single intravenous injection of MarzAA, followed by single subcutaneous injection of MarzAA, followed by daily subcutaneous injection of MarzAA for 50 days at final dose level required.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Phase 2, multi-center, open-label study designed to evaluate the PK, bioavailability, PD,
      efficacy and safety of a daily subcutaneous [SC] treatment regimen with MarzAA for bleeding
      prophylaxis in 12 adult subjects with hemophilia A or B with an inhibitor and history of
      frequent spontaneous bleeding episodes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Severe congenital hemophilia A or B with an inhibitor.

          -  History of frequent spontaneous bleeding episodes.

          -  Male, age 18 or older.

          -  Affirmation of informed consent with signature confirmation before any trial-related
             activities.

        Exclusion Criteria:

          -  Receiving prophylaxis treatment.

          -  Previous participation in a clinical trial evaluating a modified rFVIIa agent.

          -  Known positive antibody to FVII or FVIIa detected by central laboratory at screening.

          -  Have a coagulation disorder other than hemophilia A or B.

          -  Significant contraindication to participation.
Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders
Condition: Fetal Alcohol Spectrum Disorders
MeSH terms: Fetal Alcohol Spectrum Disorders
Intervention: Choline bitartrate; Placebo
Intervention MeSH terms: Choline
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: 2 Years
Maximum age: 5 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, placebo-controlled trial of choline supplementation in
      children with Fetal Alcohol Spectrum Disorders (FASD). The primary outcome measures are
      cognitive measures.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Ages 2 years to 5 years of age

          2. Available parent or legal guardian capable of giving informed consent for
             participation.

          3. Documented prenatal alcohol exposure (self-report, social service records, or adoption
             records).

          4. Modified Institute of Medicine (IOM) criteria for Fetal Alcohol Syndrome (FAS),
             Partial Fetal Alcohol Syndrome (PFAS), or Alcohol-Related Neurodevelopmental Disorder
             (ARND) (Hoyme, May, et al., 2005).

        Exclusion Criteria:

          1. Known history of a neurological condition (ex. epilepsy, traumatic brain injury)

          2. Known history of a medical condition known to affect brain function.

          3. Known history of other neurodevelopmental disorder (ex. autism, Down syndrome)

          4. Known history of very low birthweight (<1500 grams)
The Effect of Naltrexone and Varenicline on Alcohol-Mediated Smoking Lapse
Condition: Smoking
Intervention: naltrexone; varenicline; placebo
Intervention description: 25 mg/day, with 1-week lead-in medication period. The starting dose is 0 mg/day for days 1-3, followed by 12.5mg/day for day 4, followed by 25mg/day for days 5-7, plus during the laboratory session (day 8).; 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8).; placebo
Intervention MeSH terms: Naltrexone; Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 21 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: smoking lapse behavior; smoking cessation; varenicline; naltrexone; medication effect on smoking lapse behavior

Summary:

      The purpose of this study is to examine how medications thought to attenuate the effects of
      alcohol (naltrexone) and smoking cessation medications (varenicline) affect the ability to
      resist smoking and also subsequent ad-lib smoking, following a low-dose alcohol priming
      drink, in non-treatment seeking alcohol-drinking daily smokers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ages 21-55

          -  ability to read and write in English

          -  alcohol-drinking smokers

        Exclusion Criteria:

          -  any significant current medical conditions that would contraindicate smoking

          -  current DSM-IV abuse or dependence of other substances, other than nicotine dependence
             or alcohol abuse.

          -  positive test result at intake appointments on urine drug screens conducted for
             opiates, cocaine, or benzodiazepines

          -  women who are pregnant or nursing

          -  suicidal, homicidal or evidence of current severe mental illness

          -  participants prescribed any psychotropic drug in the 30 days prior to study enrollment

          -  blood donation within the past 6 weeks

          -  individuals seeking treatment for smoking cessation or drinking or have attempted to
             quit smoking or drinking within the past 3 months

          -  specific exclusion for administration of naltrexone not specified above including
             chronic pain conditions necessitating opioid treatment, and evidence of significant
             hepatocellular injury as evidenced by SGOT or SGPT > 3x normal or elevated bilirubin

          -  known allergy to varenicline or taking H2blockers (e.g., Cimetidine)

          -  participation within the past 8 weeks in other studies that involve additive blood
             sampling and/or interventional measures that would be considered excessive in
             combination with the current protocol
Pharmacokinetics, Pharmacodynamics, and Impact of Inorganic Nitrate on Exercise in HFpEF
Condition: Heart Failure; Diastolic Heart Failure
MeSH terms: Heart Failure; Heart Failure, Diastolic
Intervention: KNO3; KCl
Intervention description: Active Comparator; Placebo Comparator
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will be performed to determine the safety, tolerability, and dose-response to
      inorganic nitrate on exercise capacity in HFpEF. There are two primary goals for this study:

        1. Determine the population-specific pharmacokinetics and dose of KNO3 that can be safely
           given to subjects with HFpEF.

        2. Determine if there is a dose-response effect of nitrate supplementation on exercise
           capacity, evidenced by peak oxygen consumption (peak VO2), and physiologic adaptations
           to exercise.
    

Eligibility criteria:

        Inclusion Criteria:

          1. NYHA Class II-III symptoms.

          2. LV EF > 50%.

          3. Stable medical therapy for at least 1 month.

          4. Evidence of significant diastolic dysfunction, meeting the European Society of
             Echocardiography criteria for HFpEF.

        Exclusion Criteria

          1. Any rhythm other than sinus with native conduction.

          2. Inability to exercise.

          3. Moderate or greater valvular disease.

          4. Hypertrophic, infiltrative, or inflammatory cardiomyopathy.

          5. Pericardial disease.

          6. Current angina.

          7. Acute coronary syndrome or coronary intervention within the past 2 months.

          8. Primary pulmonary arteriopathy.

          9. Clinically significant lung disease.

         10. Ischemia on stress testing without subsequent revascularization.

         11. Treatment with phosphodiesterase inhibitors that cannot be withheld.

         12. Treatment with organic nitrates or allopurinol.

         13. Significant liver disease impacting synthetic function or volume control.

         14. Poor echocardiographic windows.

         15. eGFR < 30 mL/min/m2 or Cr >2.5.

         16. Current smoking.

         17. Alcohol dependency.

         18. History of Barret's esophagus.

         19. G6PD deficiency

         20. Methemoglobinemia - baseline methemoglobin level >3% prior to any study medication.
DUR-928 in Subjects With SARS-CoV-2 With Acute Lung, Liver or Kidney Injury
Condition: SARS-CoV-2
Intervention: DUR-928; Placebo
Intervention description: IV infusion; IV infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 3:1 randomization DUR-928:placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Evaluate safety and efficacy of DUR-928 in treatment of acute organ failure in subjects
      infected with SARS-CoV-2
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hospitalized with moderate, severe, or early critical COVID-19 illness diagnosed by
             RT- PCR

          -  Acute liver injury (including acute on chronic liver disease) or acute kidney injury
             or moderate COVID-19 pneumonia

        Exclusion Criteria:

          -  Critical COVID-19 illness (MAP < 60 mm Hg, on mechanical ventilator for ≥ 5 days)

          -  On maintenance hemodialysis or peritoneal dialysis

          -  Child Pugh C cirrhosis

          -  Hepatorenal syndrome

          -  Ascites and/or hepatic encephalopathy

          -  History of end stage renal disease or CKD with eGFR < 15 mL/min/1.73m2

          -  Women who are pregnant or breast feeding

          -  Receipt of other concomitant experimental therapies
Safety and Effect of Doxycycline in Patients With Amyloidosis
Condition: Amyloidosis
MeSH terms: Amyloidosis
Intervention: Doxycycline 100 mg po bid x 12 months
Intervention description: 100mg by mouth twice daily for 1 year.
Intervention MeSH terms: Doxycycline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: AL Amyloidosis; Primary Amyloidosis; Hereditary Amyloidosis; Familial Amyloidosis; SSA Amyloidosis; Senile Systemic Amyloidosis; AA Amyloidosis; Secondary Amyloidosis; Localized Amyloidosis; Systemic Amyloidosis

Summary:

      The tetracycline antibiotic doxycycline disrupts A beta amyloid fibrils (AB) in Alzheimer's
      disease, transthyretin (ATTR) amyloid fibrils in familial amyloidotic polyneuropathy, and
      immunoglobulin light chain (AL) amyloid fibrils in transgenic mouse models of disease. If
      untreated, amyloid deposits impair organ function, affecting the morbidity and mortality of
      patients.

      This single-center, twelve-month, open-label, prospective, pilot phase II study aims to
      determine whether doxycycline reduces amyloid deposits and improves organ function in
      patients with systemic or localized amyloidosis.

      The investigators plan to enroll patients with measurable amyloid disease according to
      internationally-accepted diagnostic criteria. Patients must have stable organ function at
      enrollment. Eligible subjects not receiving active treatments for amyloidosis affecting their
      kidneys, heart, aerodigestive tracts, peripheral or autonomic nervous system(s), lungs, eyes,
      skin, bladder, or breasts will undergo evaluations at baseline, 6 months, and 12 months - or
      more frequently as clinically indicated.

      Over 45 years experience indicates doxycycline is a safe, well tolerated antibiotic. The
      investigators will use standard grading systems to assess doxycycline response following
      twelve months of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 or older

          -  Biopsy-proven amyloidosis

          -  Biochemical or clinical evidence of amyloid induced end-organ dysfunction

        Exclusion Criteria:

          -  Concurrent use of other tetracyclines

          -  Ongoing active treatment for amyloidosis

          -  Pregnancy or unwillingness to use contraception by women of childbearing age

          -  Doxycycline drug allergy/hypersensitivity

          -  ECOG performance status > 3

          -  NYHA class > 3

          -  Renal insufficiency (estimated creatinine clearance < 25 ml/min)

          -  Transaminitis (AST or ALT > 5 times upper limit of normal)

          -  Diabetes mellitus or hemoglobin A1C > 6.2%