bioihbjkbjnl/mcl2 huggingface dataset:
An Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease
Condition: Ulcerative Colitis; Crohn's Disease
MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Ulcer
Intervention: UTTR1147A
Intervention description: UTTR1147A will be administered based on disease status, as described in the protocol.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 143.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study will evaluate the long-term safety and tolerability of UTTR1147A in participants
      with moderate to severe ulcerative colitis (UC) or Crohn's disease (CD), enrolling up to 320
      participants from the parent studies: Phase Ib Study GA29469 (NCT02749630) and Phase II Study
      GA39925 (NCT03558152).
    

Eligibility criteria:

        Inclusion Criteria:

        Inclusion Criteria for Study Entry:

          -  Prior enrollment in Study GA29469 or Study GA39925 and meeting protocol defined entry
             criteria

        Inclusion Criteria for Study Entry and Study Re-Entry:

          -  Ability to comply with requirements of the study, in the investigator's judgment

          -  For women and men: use of highly effective contraception as defined by the protocol.

        Exclusion Criteria:

        Exclusion Criteria for Study Entry:

          -  Withdrawal of consent from parent study

          -  Discontinuation of study drug as required by the parent study protocol

          -  Discontinuation of study drug and withdrawal from Study GA29469 prior to Day 85 or
             from Study GA39925 prior to Week 8

          -  Noncompliance in the parent study, specifically defined as missing scheduled visits or
             non-adherence with background medications and concomitant medications

        Exclusion Criteria for Study Entry and Study Re-Entry:

          -  Pregnant or breastfeeding, or intending to become pregnant during the study or within
             8 weeks after the final dose of study drug or within 18 weeks after the final dose of
             study drug from GA39925, whichever is longer

          -  Any new malignancy, significant uncontrolled comorbidity, such as cardiac, pulmonary,
             renal, hepatic, endocrine, or gastrointestinal disorders, or signs or symptoms of
             infection judged by the investigator to be clinically significant since enrolling in
             the parent study

          -  Use of prohibited therapies as defined in the parent study

          -  Abnormal laboratory values, as defined in the protocol, recorded at the last visit in
             the parent study

        Exclusion Criterion for Study Re-Entry:

          -  Use of prohibited concomitant therapy since enrolling in the extension study
An Extension Study to Further Evaluate the Safety, Tolerability of GBT440 in Patients With Sickle Cell Disease Who Participated in the Study GBT440-001
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Intervention: GBT440
Intervention description: Oral drug
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      This is an open label, single arm study which enrolled 5 subjects with SCD who previously
      participated in the GBT440-001 study (NCT02285088).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects with SCD aged 18 to 60 years inclusive and >50 kg who have
             participated in the GBT440-001 study.

          2. Subjects, who if female and of child bearing potential, agree to continue to use
             highly effective methods of contraception prior to enrollment in this study and for 3
             months after the last dose of study drug.

          3. Subjects, who if male are willing to continue to use barrier methods of contraception,
             prior to enrollment in this study to 3 months after the last dose of study drug.

        Exclusion Criteria:

          1. Subjects requiring chronic transfusion therapy.

          2. Subjects receiving a blood transfusion within 30 days of enrollment in this study.

          3. Female subjects who are pregnant, trying to become pregnant or lactating.

          4. Subjects who have a clinically relevant history or presence of respiratory,
             gastrointestinal, renal, hepatic, haematological, lymphatic, neurological,
             cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological,
             dermatological, connective tissue diseases or disorders, or additional risk factors
             for torsades de pointe (e.g., heart failure, hypokalemia, personal or family history
             of long QTc interval).

          5. Subjects who have a significant infection or known inflammatory process on admission
             to this study.

          6. Subjects who have acute gastrointestinal symptoms at the time of admission (e.g.
             nausea, vomiting, diarrhoea, heartburn).
Phase 2 Study of ISIS 681257 (AKCEA-APO(a)-LRx) in Participants With Hyperlipoproteinemia(a) and Cardiovascular Disease
Condition: Elevated Lipoprotein(a); Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Hyperlipoproteinemias; Hyperlipidemias
Intervention: ISIS 681257; Placebo
Intervention description: ISIS 681257 solution for SC injection.; Sterile normal saline (0.9% NaCl)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 286.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: IONIS-APO(a)-LRx; AKCEA-APO(a)-LRx; Dyslipidemia; Dyslipoproteinemia; Hyperlipidemia; Hyperlipoproteinemia; Hyperlipoproteinemia(a); Hyperlipoproteinemia a; Lipoprotein; Lipoprotein(a); Lipoprotein a; Lp(a); Lp a

Summary:

      This is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to
      evaluate the safety, including tolerability, of ISIS 681257 and to assess the efficacy of
      different doses and dosing regimens of ISIS 681257 for reduction of plasma Lipoprotein(a)
      [Lp(a)] levels in participants with hyperlipoproteinemia(a) and established cardiovascular
      disease (CVD).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Clinical diagnosis of CVD defined as documented coronary artery disease, stroke, or
             peripheral artery disease

          -  Lp(a) plasma level ≥ 60 mg/dL

          -  Must be on standard-of-care preventative therapy for other than elevated Lp(a) CVD
             risk factors

        Key Exclusion Criteria:

          -  Within 6 months of Screening: acute coronary syndrome, major cardiac surgery, or
             stroke/TIA

          -  Within 3 months of Screening: coronary, carotid, or peripheral arterial
             revascularization, major non-cardiac surgery, or lipoprotein apheresis

          -  Heart failure New York Heart Association (NYHA) class IV
Anticoagulation in Liver Fibrosis in Patients With Hepatitis C Virus Infection
Condition: Liver Fibrosis
MeSH terms: Infections; Hepatitis C; Virus Diseases; Hepatitis; Liver Cirrhosis; Fibrosis
Intervention: Warfarin
Intervention MeSH terms: Warfarin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: The study employed a single centred, prospective, open labelled design. Practical as well as safety concerns dictated that the study could not be conducted in a blinded fashion, since patients taking anticoagulation require monitoring. The study consisted of two 8 week phases: Phase 1 and Phase 2.
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 17 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatic fibrosis; anticoagulation; Coumarin; Warfarin; Chronic hepatitis C virus infection

Summary:

      Patients who have been treated for hepatitis C virus (HCV) infection who have failed to
      respond to anti-viral treatment are often concerned about their ongoing liver disease and are
      therefore looking for alternative treatments which might prevent fibrosis progression. This
      view is endorsed by patient representative groups (including Charles Gore at the HepC Trust)
      who have welcomed this trial protocol.

      The study is a single centred, prospective, open labelled design. Practical as well as safety
      concerns dictated that the study could not be conducted in a blinded fashion, since patients
      taking anticoagulation require monitoring. The study consisted of two 8 week phases: Phase 1
      and Phase 2. Phase 1 (observation phase, 0 to 8 weeks) and Phase 2 (treatment phase with
      warfarin anticoagulation, 8 to 16 weeks). Study completed at end of Phase 2.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged >17 years (male and female)

          -  HCV infection PCR positive

          -  ALT > 40 iu/ml

          -  Ishak fibrosis score (within last 5 years) > 2, < 5

          -  Informed consent

          -  Failed antiviral therapy for HCV in last 5 years

        Exclusion Criteria:

          -  Patients requiring anticoagulation for existing clinical indications

          -  Active peptic ulcer disease

          -  Past history of haemorrhagic stroke

          -  Thrombocytopaenia (platelets count < 100 x 109 /L)

          -  Clinical evidence of portal hypertension

          -  Known cerebrovascular abnormalities;

          -  HIV antibody positive;

          -  Alcohol abuse (>40 unites/week)

          -  Menhorragia

          -  Pregnancy
Etokimab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Condition: Chronic Rhinosinusitis
MeSH terms: Sinusitis
Intervention: Etokimab; Placebo; Mometasone Furoate Nasal Spray
Intervention description: Administered by subcutaneous injection; Administered by subcutaneous injection; Mometasone Furoate Nasal Spray (MFNS) was used from 4 weeks prior to Day 1 (Run-in period) through the end of the study. Participants used 2 actuations (50 μg/actuation) in each nostril BID, total daily dose of 400 μg. Participants intolerant to BID intranasal corticosteroids (INCS) could use the lower dose regimen of 1 actuation in each nostril BID, total daily dose of 200 μg.
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: ANB020; Etokimab; CRSwNP

Summary:

      A study to evaluate the safety and efficacy of multiple doses of etokimab in adults with
      chronic rhinosinusitis with nasal polyps.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinically confirmed diagnosis of CRSwNP

          -  Nasal polyp score (NPS) ≥ 4 out of a maximum score for both nostrils (with at least a
             score of 1 for each nostril).

          -  22 Item Sino-Nasal Outcome Test (SNOT-22) score > 15.

          -  Presence of at least two of the following symptoms prior to screening: nasal
             blockade/obstruction/congestion or nasal discharge (anterior/posterior nasal drip);
             facial pain/pressure; reduction or loss of smell

          -  Body mass index (BMI) of 18 to 42 kg/m^2 (inclusive) and total body weight > 50 kg
             (110 lb). BMI=weight (kg)/(height [m^2]).

        Exclusion Criteria:

          -  Use of investigational drugs or prohibited therapy for this study within 8 weeks
             before screening or 5 half-lives, whichever is longer.

          -  Have experienced severe life threatening anaphylactic reactions.

          -  Participation in any interventional study for the treatment of CRSwNP in the 3 months
             before screening.

          -  If female, is pregnant or lactating, or intend to become pregnant during the study
             period.

          -  History (or suspected history) of alcohol or substance abuse.

          -  Current smokers or former smokers with a smoking history of ≥ 10 pack years. If a
             patient has less than 10 pack years smoking history, he or she should have quit
             smoking at least 2 months before screening to enroll in the study.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Sodium Nitrite in Acute Myocardial Infarction
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Reperfusion Injury; Infarction
Intervention: Sodium Nitrite
Intervention description: Subjects assigned to sodium nitrite will receive an initial infusion of 6 nmol/min/kg for 48 hours. After the first six subjects have been enrolled (3 active drug, 3 control) and if there are no dose limiting toxicities, additional cohorts of six subjects each will be randomized to escalating doses of sodium nitrite versus control for a total of 30 subjects.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Acute myocardial infarction; Reperfusion injury; Nitric oxide

Summary:

      The purpose of this study is to determine whether the intravenous infusion of sodium nitrite
      safely prevents ischemia-reperfusion injury in subjects with acute myocardial infarction
      resulting in improved left ventricular function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Acute ST segment elevation myocardial infarction

          -  Eligible for percutaneous coronary intervention

        Exclusion Criteria:

          -  Cardiogenic shock

          -  Cardiac arrest

          -  Prior infarct in the infarct related artery

          -  Hemoglobinopathy, Glucose-6 Phosphate Dehydrogenase (G6PD) deficiency
A Study of Topical NS2 Cream to Treat Ichthyosis in Sjögren-Larsson Syndrome (SLS)
Condition: Sjögren-Larsson Syndrome
MeSH terms: Sjogren's Syndrome; Ichthyosis; Sjogren-Larsson Syndrome; Syndrome
Intervention: Active topical NS2 1% dermatologic cream; Vehicle placebo 0.0% NS2 dermatologic cream
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No
Keywords: Sjögren-Larsson Syndrome; SLS; FALDH Deficiency; Neuro-ichthyosis; Fatty Alcohol:NAD+ Oxidoreductase Deficiency; Fatty Aldehyde Dehydrogenase Deficiency Disease; Congenital Icthyosis Mental Retardation Spasticity Syndrome; Spastic Neurologic Disorder; Oligophrenia; Ichthyosis

Summary:

      This is a multi-center, randomized, double-blind, vehicle-controlled, parallel-group study
      designed to evaluate the safety, pharmacokinetic (PK), and exploratory activity of
      topically-applied NS2 dermatologic cream administered once-daily (QD) to subjects with
      ichthyosis secondary to Sjögren- Larsson Syndrome (SLS).

      NS2 is expected to trap fatty aldehydes that are pathogenic in SLS patients, and thereby
      diminish the lipid-aldehyde adduct formation that likely results in ichthyosis associated
      with SLS, and potentially reduce the mild dermal inflammation characteristic of SLS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Genetically-confirmed diagnosis of SLS

          -  Active ichthyosis on the lower extremities that is determined to be at least moderate
             severity

        Exclusion Criteria:

          -  Evidence of an active infection

          -  Currently receiving immunosuppressive therapy, including intermittent or low-dose
             corticosteroids and is not able or willing to suspend from 2 weeks before and during
             the study

          -  Currently receiving systemic or topical retinoids, other topically applied drugs, or
             other supplements that could interfere with dermatologic examination findings

          -  Received an investigational systemic or topically administered drug within 30 days
             before screening
Convalescent Plasma in the Treatment of COVID 19
Condition: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2); COVID; Coronavirus
MeSH terms: Coronavirus Infections; Severe Acute Respiratory Syndrome
Intervention: Convalescent Plasma
Intervention description: treatment with 2 Units of convalescent plasma
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: SARS-CoV-1, COVID, Coronavirus, convalescent plasma, plasma

Summary:

      The purpose of this study is to collect blood from previously COVID-19 infected persons who
      have recovered and use it as a treatment for those who are currently sick with a severe or
      life-threatening COVID-19 infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All genders

          -  Age > 18 yrs and < 90 yrs

          -  Must have laboratory confirmed COVID-19

          -  Must provide informed consent

          -  Must have severe or immediately life-threatening COVID-19,

        Severe disease is defined as:

          -  dyspnea,

          -  respiratory frequency ≥ 30/min,

          -  blood oxygen saturation ≤ 93%,

          -  partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300

          -  lung infiltrates > 50% within 24 to 48 hours

        Life-threatening disease is defined as:

          -  respiratory failure,

          -  septic shock

          -  multiple organ dysfunction or failure

        Exclusion Criteria:

          -  No gender exclusion

          -  Age < 18 yrs and > 90 yrs

          -  COVID-19 negative
A Study of IMR-687 in Adult Participants With Sickle Cell Anemia (Homozygous HbSS or Sickle-β0 Thalassemia)
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell; Thalassemia
Intervention: IMR-687; Placebo
Intervention description: Oral administration of IMR-687 once daily with or without HU.; Oral administration of placebo once daily with or without HU.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Double-blind
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      Study of IMR-687 in adult participants with sickle cell anemia (SCA) (homozygous HbSS or
      sickle-β0 thalassemia).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female participants with confirmed SCA

          -  Age 18 to 55 years, inclusive

          -  For participants on HU, must have been on a stable dose for at least 60 days prior to
             screening

        Key Exclusion Criteria:

          -  Total hemoglobin >12.5 or <6 grams/deciliter

          -  Red blood cell transfusion within 60 days of baseline

          -  >7 hospitalizations for vaso-occlusive crises (VOCs) within the last year

          -  Estimated glomerular filtration rate <50 milliliter/minute

          -  Aspartate aminotransferase/alanine aminotransferase >3x the upper limit of normal
Study of SPARC1103 in Subjects With Spasticity
Condition: Spasticity
MeSH terms: Muscle Spasticity
Intervention: SPARC1103 low dose; SPARC1103 high dose; SPARC Placebo
Intervention description: once daily; once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 142.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Spasticity, Multiple sclerosis

Summary:

      Study of SPARC1103 in subjects with spasticity
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women greater than or equal to 18 years of age

          -  Willing to sign the informed consent form

          -  Women of child bearing potential willing to practice an acceptable method of birth
             control

          -  Known history of spasticity due to MS

        Exclusion Criteria:

          -  Administration of an investigational drug or device within 30 days prior to Screening
             Visit 1

          -  Unable to comply with trial procedures in the opinion of the Investigator

          -  Concomitant neurologic conditions causing spasticity

          -  Any medical condition, including psychiatric disease or epilepsy, which would
             interfere with the interpretation of the trial results
Modeling Stress-precipitated Smoking Behavior for Medication Development
Condition: Smoking
Intervention: guanfacine; placebo
Intervention description: 3 mg/day, with 3-week lead-in medication period. The starting dose is 0.5 mg/day for days 1-3, followed by 1.5mg/day for days 4-7, followed by 2 mg/day for days 8-12, followed by 2.5 mg/day for days 13-15, followed by 3 mg/day from day 16 to remainder of study. 5-day taper at end of study.; placebo
Intervention MeSH terms: Guanfacine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: smoking lapse behavior; guanfacine

Summary:

      The purpose of this study is to examine whether guanfacine will attenuate the ability of
      stress to precipitate smoking lapse behavior in treatment seeking and non-treatment seeking
      daily smokers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ages 18-60

          -  able to read and write in English

          -  smokers

        Exclusion Criteria:

          -  any significant current medical conditions that would contraindicate smoking

          -  current Diagnostic and Statistical Manual IV (DSM-IV) abuse or dependence of other
             substances, other than nicotine (or caffeine) dependence

          -  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 severe mental illness

          -  participants prescribed any psychotropic drug in the 30 days prior to study enrollment

          -  blood donation within the past 6 weeks

          -  participants who have engaged in a quit attempt in the past 3 months

          -  specific exclusions for administration of guanfacine not already specified include:
             Hypotensive individuals with sitting blood pressure below 90/50 mmHG; EKG evidence at
             baseline screening of any clinically significant conduction abnormalities, including a
             Bazett's corrected QT interval (QTc) >450 msec for men and QTc>470 msec for women;
             known intolerance for guanfacine