bioihbjkbjnl/mcl2 huggingface dataset:
Dose-ranging Study of Nemolizumab in Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Nemolizumab; Placebo
Intervention description: Injection every 4 weeks during 24 weeks (last injection at week 20); Injection every 4 weeks during 24 weeks (last injection at week 20)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 226.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Assess the efficacy of several subcutaneous doses of nemolizumab in moderate-to-severe atopic
      dermatitis (AD) subjects with severe pruritus receiving TCS, who were not adequately
      controlled with topical treatments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects ≥ 18 years (or legal age when higher)

          -  Chronic AD, that has been present for at least 2 years before the visit

          -  Eczema Area and Severity Index (EASI) score ≥12

          -  Investigator Global Assessment (IGA) score ≥ 3

          -  AD involvement ≥ 10% of Body Surface Area (BSA)

          -  Severe pruritus on at least 3 of the last 7 days before the visit

          -  Documented recent history (within 6 months before the visit) of inadequate response to
             topical medications

          -  Female subjects must fulfill one of the criteria below:

               -  Female subjects of non-childbearing potential

               -  Female subjects of childbearing potential who agree to a true abstinence or to
                  use an effective or highly effective method of contraception throughout the
                  clinical trial and for 120 days after the last study drug administration

        Exclusion Criteria:

          -  Body weight < 45 kg

          -  subjects with a medical history of asthma requiring hospitalization in the last 12
             months before screening visit and/or whose asthma has not been well-controlled during
             the last 3 months before the screening visit and/or Peak Expiratory Flow (PEF) <80% of
             the predicted value

          -  Cutaneous bacterial or viral infection within 1 week before the screening visit or
             during the run-in period

          -  Infection requiring treatment with oral or parenteral antibiotics, antivirals,
             antiparasitics or antifungals within 1 week before the screening visit or during the
             run-in period

          -  History of intolerance to low or mid potency TCS or for whom TCS is not advisable
A Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Bimekizumab
Intervention description: Bimekizumab at a prespecified dose.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 184.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bimekizumab; Psoriatic Arthritis; PsA

Summary:

      This is a study to assess the long-term safety and tolerability of bimekizumab in subjects
      with psoriatic arthritis
    

Eligibility criteria:

        Inclusion Criteria:

          -  In the opinion of the Investigator, the subject is expected to benefit from
             participation in an Open Label Extension (OLE) study

          -  Subject completed PA0008 without meeting any withdrawal criteria

          -  Female subjects must be postmenopausal, permanently sterilized or, if of childbearing
             potential, must be willing to use a highly effective method of contraception

          -  Male subjects with a partner of childbearing potential must be willing to use a condom
             when sexually active

        Exclusion Criteria:

          -  Female subjects who plan to become pregnant during the study or within 20 weeks
             following the last dose of IMP. Male subjects who are planning a partner pregnancy
             during the study or within 20 weeks following the last dose

          -  Subjects with any current sign or symptom that may indicate a medically significant
             active infection (except for the common cold) or has had an infection requiring
             systemic antibiotics within 2 weeks of study entry

          -  Subjects who meet any withdrawal criteria in PA0008. For any subject with an ongoing
             Serious Adverse Event, or a history of serious infections (including hospitalizations)
             in the lead-in study, the Medical Monitor must be consulted prior to the subject's
             entry into PA0009
A Study to Evaluate the Change in Weight After 24 Weeks Treatment With LIK066 in Obese or Overweight Adults
Condition: Obesity; Overweight
MeSH terms: Overweight
Intervention: LIK066; Placebo
Intervention description: LIK066 will be supplied in different doses as tablets to be taken orally.; Placebo
Intervention MeSH terms: Licogliflozin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 460.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Obesity; Overweight

Summary:

      This was a dose-finding study that evaluated the change in weight after 24 weeks treatment
      with 8 different doses of LIK066 compared to placebo in obese or overweight adults, followed
      by 24 weeks treatment with 2 doses of LIK066 and placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          1. informed consent

          2. (BMI>=30) or (BMI>=27 with history of CV disease, hypertension, dyslipidemia,
             pre-diabetes or type 2 diabetes mellitus, sleep-apnea syndrome)

          3. willing to comply with life-style intervention and treatment during the full duration
             of the study (approximately 54 weeks)

        Exclusion Criteria:

          -  Hypersensitivity to any of the study medications

          -  Pregnancy or lactating women

          -  History of malignancies

          -  Use of pharmacologically active weight loss products

          -  Bariatric surgery

          -  Ketoacidosis, lactic acidosis, hyperosmolar coma in the 6 months before the screening
             visit.

          -  HbA1c >10% at the screening visit.
Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism
Condition: Congenital Hyperinsulinism; Hyperinsulinism; Persistent Hyperinsulinemic Hypoglycemia of Infancy; CHI; PHHI
MeSH terms: Congenital Hyperinsulinism; Nesidioblastosis; Hypoglycemia; Hyperinsulinism
Intervention: F-DOPA; PET scan
Intervention description: 0.08-0.16 mCi/kg once
Intervention MeSH terms: Dihydroxyphenylalanine
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 106.0
Sex: All
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Congenital Hyperinsulinism; Hyperinsulinism; Persistent Hyperinsulinemic Hypoglycemia of Infancy; CHI; PHHI; F-DOPA; L-fluoro-dihydroxyphenylalanine

Summary:

      Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these
      children may require surgery. In this study, researchers affiliated with the University of
      Pennsylvania will test how well a radioactive drug (called F-DOPA) can detect a form of
      hyperinsulinism that may be cured by surgery. Eligible participants in this study will have
      positron emission tomography (PET) scans with F-DOPA prior to surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any age, but primarily infants 0-6 months.

          -  Children with confirmed diagnosis of congenital hyperinsulinism.

        Exclusion Criteria:

          -  Cases in which surgery will not be considered by parents or guardians.
Octreotide for Management of Bronchorrhea in Mechanically Ventilated Patients
Condition: Octreotide; Sputum
Intervention: Octreotide
Intervention MeSH terms: Octreotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether administration of octreotide (12-25
      mcg/hour) for 72 hours in combination with the standard of care treatment is effective in
      reducing bronchorrhea (excessive airway secretions) in mechanically ventilated patients. The
      use of this drug (octreotide) to manage bronchorrhea has not been approved by the United
      States Food and Drug Administration (FDA) and is used as an experimental drug in this
      research study. We are anticipating to enroll approximately 30 subjects in this study at
      Danbury Hospital, with 15 patients randomly assigned to the "Routine Care" group, which will
      serve as the control group, and 15 patients randomly assigned to the octreotide group.
      Control group will only receive the standard of care and will not receive this drug. Total
      subject participation in this study will be for 4 days (96 hours) or until their breathing
      tube is removed (extubation), whichever occurs first.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients are being weaned from mechanical ventilation

          -  Excessive bronchial secretions (over 200 ml/24 hours) is deemed by the Primary Team to
             be a major barrier to extubation

        Exclusion Criteria:

          -  Known hypersensitivity to octreotide

          -  Persistent bradycardia (HR < 60)

          -  Mobitz type II or 3rd degree heart block in patients without a pacemaker

          -  Patients being treated with intravenous agents for hypertensive urgency or emergency

          -  Surgical patients

          -  Initiation of therapy with systemic or inhaled steroids within 72 hours prior to the
             enrollment into the study, as these may further change the rate of secretions*

          -  Initiation of therapy with systemic or inhaled anticholinergics within 48 hours prior
             to the enrollment into the study, as these may further change the rate of secretions
Gallium-68 Prostate Specific Membrane Antigen PET in Diagnosing Patients With Thyroid Cancer
Condition: Thyroid Gland Carcinoma
MeSH terms: Thyroid Neoplasms; Thyroid Diseases
Intervention: Gallium Ga 68-labeled PSMA-11; Magnetic Resonance Imaging; Positron Emission Tomography (PET)
Intervention description: Given IV; Undergo MRI in combination with PET; Undergo PET in combination with MRI
Intervention MeSH terms: Gallium 68 PSMA-11
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This pilot clinical trial studies how well Gallium-68 prostate specific membrane antigen
      positron emission tomography (PET) work in diagnosing patients with thyroid cancer.
      Diagnostic procedures, such as 68Ga-PSMA PET, may more accurately diagnose thyroid cancer and
      find out how far the disease has spread.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of thyroid cancer

          -  Whole body 18F-FDG PET/computed tomography (CT) or I-131 scintigraphy within the past
             90 days of the scheduled 68Ga-PSMA PET demonstrating uptake

          -  Creatinine =< 3.0 mg/dL

          -  Ability to understand a written informed consent document, and the willingness to sign
             it

        Exclusion Criteria:

          -  Patients who have had active infection within 15 days of study enrollment that may be
             considered to interfere with 68Ga-PSMA PET imaging by the study investigators

          -  Patients who are unable to have placement of intravenous line access

          -  Pregnant or breastfeeding women

          -  Patients not capable of undergoing a PET/MRI study due to weight, claustrophobia, or
             inability to lie still for the duration of the exam
Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects
Condition: Diabetes; Metabolic Syndrome x
MeSH terms: Metabolic Syndrome; Syndrome
Intervention: borage/echium oil combination; fish oil; corn oil
Intervention description: borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA; 1.6g/day EPA and 1.08g/day DHA; contains 4.5 g/day linoleic acid
Intervention MeSH terms: Borage oil
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 80.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: diabetes; metabolic syndrome; inflammation; botanical oils

Summary:

      This study will compare how well a combination of borage and echium oils will reduce
      inflammation compared to fish oils and placebo oil in subjects that are diabetic or have
      metabolic syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adults, aged 21 years or more with either diabetes or metabolic syndrome. metabolic
             syndrome defined by NCEP/ATPIII criteria; must have 3 out of 5 of the following risk
             factors: 1.central obesity, men-greater than or equal to 40 inches, women-greater than
             or equal to 35 inches; 2.fasting blood TG greater than or equal to 150mg/dl or be
             taking TG lowering medications; 3. blood HDL cholesterol, men less than 40 mg/dl,
             women less than 50 mg/dl; 4. blood pressure greater than or equal to 130/85 or on HTN
             medication 5. fasting glucose greater than or equal to 100 mg/dl.

          -  participants on statins or glucose lowering drugs if dosages are stable for 3 months

        Exclusion criteria

          -  children/young adults less than 21 years of age

          -  currently using anti-inflammatory drugs including NSAIDS, oral/IV steroids or
             injection antiinflammatory drugs(for RA), aspirin greater than 100mg/day

          -  taking leukotriene receptor antagonists ( montelukast), tylenol or nasal/inhaled
             steroids OK.

          -  currently using niacin, fibrates or fish oil

          -  blood pressure greater than 170/100

          -  HB1Ac greater than 10%

          -  TG greater than 500 mg/dl

          -  myocardial infarction/vascular surgery/stroke within the past year

          -  any stage II,III,IV heart failure

          -  prior cholecystectomy

          -  end stage renal disease

          -  BMI less than 23 or greater than 45

          -  pregnancy

          -  alcohol use greater than 14 drinks per week

          -  current self reported tobacco or illicit drug use

          -  intolerance or allergy to fish oil

          -  participants taking insulin on QD or BID doses, stable for 3 months
Bempedoic Acid + Ezetimibe Fixed-Dose Combination (FDC) Study in Patients With Type 2 Diabetes and Elevated LDL-C
Condition: Diabetes; Diabetes Mellitus, Type 2; Cholesterolemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Bempedoic acid + Ezetimibe FDC Oral Tablet; Ezetimibe 10 mg Oral Tablet; Placebo Oral Tablet; Placebo oral capsule
Intervention description: Experimental therapy of bempedoic acid 180 mg + ezetimibe 10 mg FDC tablet; Ezetimibe 10 mg tablet, overencapsulated for blinding purposes; Placebo tablet, matched for the FDC product for blinding purposes; Placebo over-encapsulated for blinding purposes
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid; Ezetimibe
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 242.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: diabetes; cholesterolemia; type 2 diabetes; LDL-C; T2D; diabetes mellitus

Summary:

      12 week study to assess the LDL-C lowering efficacy, other lipid and glycemic measures, and
      safety of bempedoic acid/ezetimibe FDC compared to ezetimibe and placebo in patients with
      type 2 diabetes (T2D) and elevated LDL-C
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes for 6 months or greater

          -  Currently taking stable diabetes medication for 3 months or greater

          -  HbA1c between 7-10%

          -  LDL-cholesterol greater than 70 mg/dL

          -  Women must not be pregnant, lactating, or planning to become pregnant within 30 days
             after last dose of study medication; and must be postmenopausal, surgically sterile,
             or willing to use 1 acceptable form of birth control during the study through 30 days
             after the last dose of study medication

        Exclusion Criteria:

          -  Body mass index > 40 kg/m2

          -  History of documented clinically significant cardiovascular disease

          -  Fasting triglycerides > 400 mg/dL

          -  History of Type 1 diabetes

          -  Uncontrolled hypothyroidism, liver dysfunction, renal dysfunction, gastrointestinal
             condition that may affect drug absorption, hematologic or coagulation disorder or
             active malignancy

          -  History of drug or alcohol abuse within 2 years
Selinexor Treatment of Refractory Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Selinexor; Dexamethasone
Intervention description: Fixed oral dose of 80 mg twice weekly (e.g., Monday and Wednesday or Tuesday and Thursday, etc.); 20 mg was given with each dose of Selinexor.
Intervention MeSH terms: Dexamethasone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 202.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple myeloma; Karyopharm; KPT-330; Selinexor; Refractory; Bortezomib; Carfilzomib; Lenalidomide; Pomalidomide; Dexamethasone; STORM; Daratumumab

Summary:

      This is a Phase 2b, single-arm, open-label, multicenter study of selinexor 80 mg plus
      dexamethasone 20 mg (Sd) dosed twice weekly in four-week cycles, in patients with
      penta-refractory MM (Parts 1 and 2) or quad refractory MM (Part 1 only).
    

Eligibility criteria:

        Inclusion Criteria:

        Measurable MM based on modified IMWG guidelines. Defined by at least one of the following:

          1. Serum M-protein ≥ 0.5 g/dL by serum electrophoresis (SPEP) or for IgA myeloma, by
             quantitative IgA

          2. Urinary M-protein excretion ≥ 200 mg/24 hours

          3. Free Light Chain (FLC) ≥ 100 mg/L, provided that the FLC ratio is abnormal

          4. If serum protein electrophoresis is felt to be unreliable for routine M-protein
             measurement, then quantitative Ig levels by nephelometry or turbidimetry are
             acceptable

               -  Must have previously received ≥ 3 anti-MM regimens including: an alkylating
                  agent, lenalidomide, pomalidomide, bortezomib, carfilzomib, daratumumab, and a
                  glucocorticoid. There is no upper limit on the number of prior therapies provided
                  that all other inclusion/exclusion criteria are met.

               -  MM refractory to previous treatment with one or more glucocorticoids, parenteral
                  PI (i.e., bortezomib and/or carfilzomib), IMiD (i.e., lenalidomide and/or
                  pomalidomide), and the anti-CD38 mAb, daratumumab. Refractory is defined as ≤ 25%
                  response to therapy, or progression during therapy or progression within 60 days
                  after completion of therapy.

        Exclusion Criteria:

          -  Active smoldering MM.

          -  Active plasma cell leukemia.

          -  Documented systemic amyloid light chain amyloidosis.

          -  Active CNS MM.
The Long-term Safety and Efficacy of CDP6038 (Olokizumab) With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: CDP6038 (olokizumab)
Intervention description: Biological/Vaccine: CDP6038 (olokizumab) 100 mg/mL solution for subcutaneous (sc) injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: RA0089 is a single arm study, however, analysis will also be performed according to the original treatment arms of the parent study NCT01463059 (RA0083).
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; Monoclonal antibody; Interleukin-6; Olokizumab; CDP6038

Summary:

      The purpose of this study is to evaluate the long-term safety and tolerability of CDP6038
      (olokizumab) treatment in adult subjects with active rheumatoid arthritis (RA) who completed
      study RA0083 [NCT01463059].
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed the RA0083 [NCT01463059] study (Week 12 Visit)

          -  Must have maintained their stable dose (and route) of methotrexate (MTX) between 6 to
             16 mg/week in Japan or 7.5 to 20 mg/week in Korea and Taiwan in RA0083 [NCT01463059],
             and plan to maintain this same dose and route of administration for at least 12 weeks

          -  Female subjects must be either postmenopausal for at least 1 year, surgically
             incapable of childbearing, or effectively practicing 2 acceptable methods of
             contraception

        Exclusion Criteria:

          -  Have an ongoing SAE from the RA0083 [NCT01463059] study

          -  Female subjects who are breast-feeding, pregnant, or plan to become pregnant during
             the study or within 24 weeks

          -  Have evidence of active or latent tuberculosis (TB)

          -  Subject is receiving any biologic response modifier or synthetic disease-modifying
             antirheumatic drug (DMARD) other than MTX

          -  Subject has planned surgery during the first 12 weeks of the study

          -  Subjects who tested positive for hepatitis B core antibody (HBcAb) and/or hepatitis B
             surface antibody (HBsAb) at Screening in RA0083 [NCT01463059] and who subsequently
             test positive for hepatitis B virus deoxyribonucleic acid (HBV DNA) at Week 12 of
             RA0083 [NCT01463059]