bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety Study of BMS-986142 in Patients With Moderate to Severe Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: BMS-986142; Placebo; Methotrexate
Intervention description: BMS986142 specific dose on specific days; Placebo of BMS-986142 specific dose on specific days; Methotrexate specific dose on specific days
Intervention MeSH terms: Methotrexate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 508.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether the study drug, BMS-986142, is safe and
      effective in treating moderate to severe rheumatoid arthritis in subjects with an inadequate
      response to methotrexate or methotrexate and up to 2 tumour necrosis factor (TNF) Inhibitors.
      Patients who qualify will be randomized to either one of 3 doses of BMS-986142 or placebo in
      1:1:1 randomization for 12 weeks. Disease activity and safety will be assessed over the
      course of the study.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Male and female age 18 and above

          -  Diagnosed with active rheumatoid arthritis (RA) by standard criteria at least 16 weeks
             before screening, have functional ACR class I-III

          -  Have an inadequate response to methotrexate

          -  In addition to an inadequate response to methotrexate have an inadequate response or
             intolerance to 1 but not more than 2 TNF inhibitors

          -  Have a minimum of 6 swollen and 6 tender joints (from 66/68 joint count)

          -  Have hsCRP of ≥ 0.8 mg/dL (8mg/L) [by central laboratory values] or an ESR ≥ 28 mm/hr

          -  Willing to use effective birth control for the entire length of the study

        Exclusion Criteria:

          -  Diagnosed with juvenile Rheumatoid Arthritis

          -  Have been treated with other biologic treatment than a TNF inhibitor

          -  Active systemic bacterial, viral or fungal infection or evidence of prior or current
             Hepatitis B or C infection or HIV infection, latent bacterial, viral or fungal
             infections

          -  Have been treated with Intramuscular or Intra-articular glucocorticosteroids within 4
             weeks of randomization

          -  Taking Oral steroids at dose above 10 mg/day of prednisone (or prednisone equivalents)

          -  Have other autoimmune disease other than RA like lupus, multiple sclerosis

          -  Have significant concurrent medical condition at the time of screening or baseline
             visit
A Study of LCZ696 in Subjects With Mild and Moderate Hepatic Impairment Compared With Normal Healthy Volunteers
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Intervention: LCZ696
Intervention MeSH terms: Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 2
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: hepatic impairment

Summary:

      This is a study to characterize the pharmacokinetics as well as safety and tolerability of a
      single oral dose of LCZ696 200 mg in subjects with mild and moderate hepatic impairment
      compared to matched healthy subjects
    

Eligibility criteria:

        Inclusion Criteria:

          -  All subjects:

               -  Male and female subjects aged 18-75 years.

               -  Body weight at least 55 kg with a body mass index between 18-35 kg/m2.

          -  Hepatic impairment subjects:

               -  Mild or moderate hepatic impairment.

        Exclusion Criteria:

          -  All subjects:

               -  Clinical manifestations of postural symptomatic hypotension at screening or
                  baseline.

               -  History of hypersensitivity to LCZ696 or to drugs of similar classes.

          -  Hepatic impairment subjects:

               -  Hepatic impairment due to non-liver disease.

               -  Treatment with any vasodilator, autonomic alpha blocker or beta2 agonist within 2
                  weeks of dosing.

               -  Encephalopathyy Stage III or IV.

               -  Primary biliary liver cirrhosis or biliary obstruction.

               -  History of gastro-intestinal bleeding within 3 months prior to screening.

          -  Healthy subjects:

               -  Any surgical or medical condition which might significantly alter the
                  distribution, or excretion of drugs, or which may jeopardize the subject in case
                  of participation in the study.

               -  Use of prescription drugs, herbal supplements, and/or over-the-counter
                  medication, dietary supplements (vitamins included) within 2 weeks prior to
                  initial dosing.

        Other protocol-defined inclusion/exclusion criteria may apply.
A Study Designed to Test the Effectiveness and Safety of Treating Patients With Lacosamide for Migraine Prophylaxis
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Lacosamide; Placebo; Lacosamide
Intervention description: Lacosamide 100mg immediate-release film-coated tablet (white,oval) oral administration twice daily 12 hours apart; Immediate-release film coated tablet (white, oval), oral administration twice daily 12 hours apart; Lacosamide 300mg, immediate-release film coated tablet (white,oval), oral administration twice daily 12 hours apart.
Intervention MeSH terms: Lacosamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 218.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Lacosamide; migraine prophylaxis; Vimpat

Summary:

      The purpose of this study is to see how safe and effective Lacosamide (LCM) is when taken by
      mouth, twice a day for up to 18 weeks to prevent migraines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of migraines headaches for 1 year and well documented 3 month retrospective
             history of migraines.

          -  Experience 2-8 migraines per month but not more than 15 headache days per month. There
             should be at least 48 hours of freedom between headaches.

          -  On effective stable abortive medication(s) for the acute treatment of migraine.

        Exclusion Criteria:

          -  Subject in another investigational drug or device study within the last 30 days or is
             currently in another investigational drug trial.

          -  Use of triptans or ergots for migraine abortive treatment > 2-3 days per calendar week
             2 months prior to screening.

          -  Experience 15 or more headache days per month of any kind 2 months prior to screening.

          -  Has another consistent or chronic form of headache.

          -  Unable to stop medications, herbs, vitamins, or minerals used to prevent a migraine
             from occurring.

          -  Pregnant or nursing women and those of child bearing potential who are not surgically
             sterile, or 2 years post menopausal, or do not practice 2 combined methods of birth
             control, unless sexually abstinent, during the trial.

          -  Significant laboratory or electrocardiograms (ECG) abnormalities

          -  Significant medical history including cardiovascular abnormalities.
Trial of IMO-8400 in Adult Patients With Dermatomyositis
Condition: Dermatomyositis
MeSH terms: Dermatomyositis
Intervention: IMO-8400 Dose Group 1; IMO-8400 Dose Group 2; Placebo
Intervention description: IMO-8400 Dose 1 subcutaneous injections once a week for 24 weeks.; IMO-8400 Dose 2 subcutaneous injections once a week for 24 weeks.; normal saline subcutaneous injections once a week for 24 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: dermatomyositis; IMO-8400; Pioneer

Summary:

      The purpose of this study is to determine how safe and effective IMO-8400 is in adults with
      dermatomyositis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has definite or probable DM based on the criteria of Bohan and Peter

          -  Has a Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)-Activity score
             ≥15

          -  Patients with muscle weakness are eligible; however having muscle weakness is not
             mandatory.

          -  Study participants must have a diagnostic evaluation for cancer if the diagnosis of DM
             was within 2 years prior to the Screening Visit

        Exclusion Criteria:

          -  Has ongoing severe dysphagia (e.g., requires a feeding tube) for the 3 months prior to
             Screening

          -  Has known hypersensitivity to any oligodeoxynucleotide

          -  Has a history of drug or alcohol abuse within one year of screening, or evidence of
             drug abuse by urine drug screening

          -  Has body weight >140 kg

          -  Has a diagnosis of Juvenile DM, IBM, drug-induced toxic myopathy, metabolic myopathy,
             dystrophy, cancer-associated DM, or connective tissue disease-associated DM (e.g.,
             overlap syndrome)

          -  Has received one or more of following prohibited treatments within the interval noted
             prior to Screening (Visit 1):

               1. Rituximab within 24 weeks (Note: patients who received rituximab are only
                  eligible for inclusion if B-cell counts are confirmed to be within normal limits)

               2. Intravenous corticosteroids within 12 weeks

               3. Antimalarials (e.g., hydroxychloroquine) within 36 weeks

               4. Topical corticosteroids (excluding scalp) within 2 weeks

          -  Has evidence of or has required treatment for cancer (except for treated, non-invasive
             carcinoma of the skin or cured cervical carcinoma-in-situ) within 5 years

          -  Has interstitial lung disease requiring the use of supplemental oxygen
CLG561 Proof-of-Concept Study as a Monotherapy and in Combination With LFG316 in Subjects With Geographic Atrophy (GA)
Condition: Geographic Atrophy
MeSH terms: Geographic Atrophy; Atrophy
Intervention: CLG561; LFG316; Sham injection
Intervention description: Empty syringe (without a needle) placed against the eye
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 114.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Geographic atrophy (GA); Macular degeneration; Dry age-related macular degeneration (AMD); Intravitreal (IVT); Retinal diseases; Fundus auto fluorescence (FAF)

Summary:

      The purpose of this study is to evaluate the safety and efficacy of 12 (every 28 days)
      intravitreal (IVT) injections of CLG561 as a monotherapy and in combination with LFG316 as
      compared to sham in subjects with geographic atrophy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sign written informed consent form;

          -  Geographic atrophy in both eyes;

          -  Other protocol-specified inclusion criteria may apply.

        Exclusion Criteria:

          -  Pregnant or lactating women and women of child-bearing potential;

          -  Any medical condition (systemic or ophthalmic) that may preclude the safe
             administration of test article or safe participation in this study;

          -  Any contraindications or hypersensitivities to any component of the LFG316 or CLG561
             solution;

          -  Any contraindications to IVT injections;

          -  Ocular surgery in either eye within 90 days of screening;

          -  Uncontrolled ocular hypertension or glaucoma in the study eye;

          -  Other protocol-specified exclusion criteria may apply.
Blood Lipopolysaccharide (LPS) Rifaximin Study
Condition: Obese; Insulin Resistance; Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Insulin Resistance
Intervention: Rifaximin SSD; Placebo
Intervention description: Study Drug dosing will be 80 mg SSD once daily; 80 mg placebo once daily
Intervention MeSH terms: Rifaximin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 12.0
Sex: All
Minimum age: 35 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: obese; insulin resistance; metabolic syndrome

Summary:

      Metabolic syndrome is a condition involving elevated levels of fat in the blood, a tendency
      towards diabetes, hypertension, and too much fat around the abdomen (an increased waistline).
      Individuals with metabolic syndrome often have impaired glucose tolerance, which is a
      condition where blood sugar is normal when fasting (before eating), but is too high after
      drinking a sugary drink. This is due to an abnormality in the body's sensitivity to insulin
      (insulin resistance), which is due in part to an inability of the muscle to take up glucose.

      People with metabolic syndrome have inflammation in their fat tissue and in their blood
      stream, and the changes in the level of inflammatory chemicals produced by cells in your fat
      tissues will be studied. One possible source of the inflammation may be the bacteria in the
      intestine. When individuals eat fatty foods, some of the bacterial products become attached
      to the fat in their blood and then get directed to fat tissue. The investigators wish to
      determine whether individuals have an excessive amount of inflammation in their fat tissues,
      and whether this inflammation comes from the bacteria in their intestines. To determine this,
      the investigators wish to treat individuals with an antibiotic that reduces the bacteria in
      their intestines and in their blood, and determine whether this reduces their overall level
      of inflammation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Obese

          -  Insulin resistance or metabolic syndrome

          -  Body Mass Index between 27 and 45

          -  Waist circumference >40" (M) or >35" (F)

          -  Impaired glucose tolerance (IGT)

          -  Normal glucose tolerance (NGT) with at least three features of MetS

          -  A1C <6.5

          -  Blood pressure 130/85

        Exclusion Criteria:

          -  Pregnant or breastfeeding

          -  Recent or unstable cardiovascular disease

          -  cancer,

          -  Renal insufficiency (GFR<30)

          -  Steroid use

          -  chronic inflammatory conditions

          -  Anticoagulant use

          -  Lipodystrophy

          -  Irritable Bowel Syndrome

          -  Allergy to local anesthetic

          -  Lactose intolerance
One Month Dose Response Study of AZD1981 in Asthma Patients Uncontrolled on Inhaled Steroids
Condition: Asthma
MeSH terms: Asthma
Intervention: AZD1981; AZD1981; AZD1981; Placebo
Intervention description: Oral tablet, 50 mg twice daily; Oral tablet, 400 mg twice daily; Oral tablet, 1000 mg twice daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 368.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Asthma

Summary:

      The primary objective of this study is to evaluate efficacy of AZD1981 in uncontrolled
      asthmatic patients on maintenance inhaled glucocorticosteroids.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Six months history of asthma

          -  Daily use of inhaled glucocorticosteroids

          -  FEV1 40-85% of predicted normal

          -  Reversibility; increase in FEV1 more than 12% and 200 mL post-bronchodilator

        Exclusion Criteria:

          -  Other clinically relevant disease or disorders

          -  History of smoking of more than 10 pack years

          -  Respiratory infection within 30 days
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.
A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Moderate - Severe Interdigital Tinea Pedis
Condition: Tinea Pedis
MeSH terms: Tinea; Tinea Pedis
Intervention: VT-1161; placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if the novel oral agent VT-1161 is safe and
      effective in treating patients with moderate - severe tinea pedis (also referred to as
      athletes foot). VT-1161 has been designed to inhibit CYP51, an enzyme essential for fungal
      growth. Inhibition of CYP51 results in the accumulation of chemicals know to be toxic to the
      fungus. CYP51 is the molecular target of the class of drugs referred to as 'azole
      antifungals'. All currently approved azole drugs have poor selectivity for CYP51 and this
      results in many of the side effects associated with the azole antifungals. The safety profile
      of the class similarly limits use in chronic treatment of non-life-threatening fungal
      infections. A safer antifungal drug would improve treatment options for infections seen in
      otherwise healthy individuals where significant side-effect risks are unacceptable.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Healthy male and non-pregnant female patients ≥18 years and <65 years

          -  Clinical diagnosis of tinea pedis

          -  Positive baseline KOH

          -  Clinical signs and symptoms score of the target lesion is at least 6, including a
             minimum score of at least 2 for erythema AND a minimum score of 2 for either scaling
             or pruritus (on a scale of 0-3, where 2 indicates moderate severity)

          -  Patients must be able to swallow capsules intact

          -  Use acceptable birth control methods

        Key Exclusion Criteria:

          -  Major organ system disease or clinical infection

          -  Poorly controlled diabetes mellitus

          -  Pregnant or lactating

          -  Confluent, diffuse moccasin-type tinea pedis

          -  Presence of onychomycosis involving a) more than 5 toe nails, b) any fingernail

          -  Recent use of topical corticosteroids, topical antibiotics, or topical antifungal
             therapy to the foot

          -  Recent use of systemic corticosteroids or antifungal therapy

          -  Known(HIV)infection

          -  Known significant hepatic, or hematologic impairment .Requirement for treatment with
             concomitant antimicrobial or systemic antifungal therapy for any reason.