bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes on Metformin With or Without Sulfonylurea (SURPASS-AP-Combo)
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Tirzepatide; Insulin Glargine
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Insulin Glargine; Tirzepatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 917.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: T2DM

Summary:

      The main reason for this study is to compare the study drug tirzepatide to insulin glargine
      in participants with type 2 diabetes on metformin with or without a sulfonylurea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes mellitus

          -  Treated with stable metformin with or without a sulfonylurea (metformin ≥1000
             milligrams/day; sulfonylurea should be at least half the maximum dose) for at least 2
             months

          -  Are insulin-naive (except for the use of insulin for treatment of gestational diabetes
             or short-term use [≤14 consecutive days] for acute conditions)

          -  HbA1c ≥7.5% to ≤11.0% at screening

          -  Stable weight (±5%) ≥3 months, and agree to not initiate a diet and/or exercise
             program during the study with the intent of reducing body weight other than the
             lifestyle and dietary measures for diabetes treatment

          -  Body mass Index (BMI) ≥23 kilograms per meter squared

        Exclusion Criteria:

          -  Type 1 diabetes mellitus

          -  Have history of chronic or acute pancreatitis

          -  Have history of proliferative diabetic retinopathy; or diabetic maculopathy; or
             non-proliferative diabetic retinopathy that requires acute treatment

          -  Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6
             months

          -  Have a history of ketoacidosis or hyperosmolar state/coma

          -  Have a known clinically significant gastric emptying abnormality, have undergone or
             plan to have during the course of the study, or chronically take drugs that directly
             affect GI motility

          -  Have acute myocardial infarction (MI), stroke or hospitalization due to congestive
             heart failure (CHF) within 2 months

          -  Have family or personal history of medullary thyroid carcinoma (MTC) or multiple
             endocrine neoplasia syndrome type 2 (MEN-2)

          -  Have been treated with prescription drugs that promote weight loss or similar other
             body weight loss medications including over the counter (OTC) within 3 months
NAC for Head Trauma-induced Anosmia
Condition: Anosmia; Head Trauma
MeSH terms: Craniocerebral Trauma; Anosmia; Wounds and Injuries
Intervention: N Acetyl Cysteine; Placebo oral capsule
Intervention description: 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days; 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will compare administration of N-Acetyl Cysteine (NAC) versus placebo for the
      treatment of olfactory loss due to head injury. The hypothesis is that treatment with NAC
      acutely after head injury will result in improved olfactory function
    

Eligibility criteria:

        Inclusion Criteria:

          -  Admitted to Ryder Trauma Center for observation acutely following head injury (i.e.
             concussion), with documented hyposmia or anosmia by University of Pennsylvania Smell
             Identification Test (SIT).

          -  Male or female, aged 18 years or older

          -  Provision of signed and dated informed consent form

          -  Stated willingness to comply with all study procedures and availability for the
             duration of the study

          -  Ability to take oral medication and be willing to adhere to the NAC regimen

          -  For females of reproductive potential: use of highly effective contraception for at
             least 1 month prior to screening and agreement to use such a method during study
             participation and for an additional 4 weeks after the end of NAC administration

        Exclusion Criteria:

          -  Severe trauma requiring ongoing inpatient treatment beyond 48 hours

          -  Pregnancy (based on urine screening) or lactation

          -  Known allergic reactions to components of NAC, such as Mucomyst

          -  Currently taking nitrates such as nitroglycerine and/or isosorbide regularly

          -  Currently taking azathioprine (Imuran) or cyclophosphamide (Cytoxan)

          -  Known diagnosis of cystinuria (renal condition in which cysteine supplement should be
             avoided)

          -  Febrile illness within 1 week

          -  Treatment with another investigational drug or other intervention within 3 months

          -  Active sinonasal disease by imaging and/or nasal exam, i.e. rhinosinusitis, nasal
             polyps

          -  Adults unable to consent

          -  Prisoners, employees or subordinates

          -  Individuals who are not yet adults (infants, children, teenagers). This population is
             excluded because efficacy has not yet been established in adults.
Rifamycin SV-MMX® Tablets Versus Ciprofloxacin Capsules in Acute Traveller's Diarrhoea
Condition: Traveler's Diarrhea
MeSH terms: Dysentery; Diarrhea
Intervention: Rifamycin SV-MMX®; Ciprofloxacin
Intervention description: 2 Rifamycin SV-MMX® 200 mg tablets and 1 placebo to ciprofloxacin capsule, b.i.d.; 1 ciprofloxacin 500 mg capsule and 2 placebos to Rifamycin SV-MMX® 200 mg tablets, b.i.d.
Intervention MeSH terms: Ciprofloxacin; Rifamycins; Rifamycin SV
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 835.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to prove the non-inferiority of Rifamycin SV-MMX® versus
      Ciprofloxacin for the treatment of adults with traveller's diarrhoea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent,

          -  Men or women between 18 and 85 years of age,

          -  History of arriving from their country of residence in the industrialized part of the
             world within the past 4 weeks,

          -  Presenting with acute infectious diarrhoea (defined as at least 3 unformed, watery or
             soft stools accompanied by symptoms within 24 hours preceding randomisation with
             duration of illness ≤ 72 hours),

          -  Presence of one or more signs or symptoms of enteric infection (moderate to severe
             gas/flatulence, nausea, vomiting, abdominal cramps or pain, rectal tenesmus, fecal
             urgency),

          -  Women of childbearing potential had to apply during the entire duration of the study a
             highly effective method of birth control

        Exclusion Criteria:

          -  Residency in any country with high incidence rate of TD within the past 6 months,

          -  Fever (defined as a body (oral) temperature >100.4°F or 38.0°C; antipyretic medication
             should not have been administered in the 6 hours prior to this assessment),

          -  Known or suspected infection with non-bacterial pathogen,

          -  Presence of diarrhoea of >72 hours duration,

          -  Presence of grossly bloody stool,

          -  Presence of moderate or severe dehydration (i.e. symptoms of hypovolemia such as
             orthostatic hypotension, dizziness or wrinkling of skin),

          -  History of inflammatory bowel disease or celiac disease,
18F-AV-1451 Autopsy Study
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Flortaucipir F18; PET Scan
Intervention description: 370 megabecquerel (MBq) IV single-dose; positron emission tomography (PET) scan
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 156.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This study is designed to test the relationship between ante-mortem flortaucipir Positron
      Emission Tomography (PET) imaging and tau neurofibrillary pathology associated with
      Alzheimer's disease (AD), as measured at autopsy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a projected life expectancy of ≤ 6 months

          -  Can tolerate a 20 minute PET scan

          -  Give informed consent or have a legally authorized representative to consent for study
             procedures and brain donation consistent with the legal requirements of the State in
             which they die

        Exclusion Criteria:

          -  Aggressively being treated with life sustaining measures

          -  Known to have a structural brain lesion that would interfere either with PET imaging
             or pathological assessment

          -  Clinically significant infectious disease

          -  Currently receiving any investigational medications except with permission from the
             study sponsor

          -  Participated in an experimental study with an amyloid or tau targeting agent

          -  Suspected encephalopathy due to alcoholism or end-stage liver disease

          -  Females of childbearing potential

          -  History of risk factors for Torsades de Pointes or are currently taking medication
             known to cause QT prolongation
A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: 23-PPV; 13-PCV Booster; Influenza Vaccine; KLH; OCR; TT Vaccine
Intervention description: The 23-PPV vaccine will be given as a 0.5-milliliter (mL) intramuscular (IM) injection in the deltoid muscle on Day 112 (Group A) or Day 28 (Group B).; The 13-PCV booster will be given as an IM injection in the deltoid muscle on Day 140 (select participants in Group A).; The influenza vaccine will be given as an IM injection in the deltoid muscle at any time between Day 85 and Day 144 (select participants in Group A) or any time between Day 1 and Day 85 (Group B).; KLH will be given as a 1-mg subcutaneous (SC) injection on Days 84, 112, and 140 (Group A) or Days 1, 28, and 56 (Group B).; OCR will be given as an intravenous (IV) infusion at a dose of 600 mg, with the first dose given as two infusions of 300mg 14 days apart, according to the specifications described in the corresponding Group A and Group B arms.; The TT-containing adsorbed vaccine will be given as a 0.5-mL IM injection in the deltoid muscle on Day 85 (Group A) or Day 1 (Group B).
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This multicenter, randomized, open-label study will evaluate the immune response to vaccines
      (tetanus toxoid [TT]-containing adsorbed vaccine, 23-valent pneumococcal polysaccharide
      vaccine [23-PPV] either unboosted or boosted with 13-valent pneumococcal conjugate vaccine
      [13-PCV], influenza vaccine, keyhole limpet hemocyanin [KLH]) after administration of a dose
      of ocrelizumab (OCR) in participants with relapsing multiple sclerosis (RMS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of RMS in accordance with the revised McDonald criteria

          -  Received at least one previous immunization against TT or tetanus and diphtheria
             (DT/Td) or tetanus, diphtheria, and acellular pertussis (DTaP/Tdap)

          -  Expanded Disability Status Scale (EDSS) at Screening from 0 to 5.5 points, inclusive

          -  For sexually active female participants of reproductive potential, use of reliable
             means of contraception

        Exclusion Criteria:

          -  Contraindications for or intolerance to oral or IV corticosteroids, including IV
             methylprednisolone, according to the country label

          -  Known presence of other neurologic disorders

          -  Treatment with any investigational agent within 24 weeks of screening or 5 half-lives
             of the investigational drug, whichever is longer, or treatment with any experimental
             procedure for multiple sclerosis
Disease Management for Smoking Cessation
Condition: Smoking Cessation
Intervention: High intensity disease management; Low intensity disease management; Comparison group; Bupropion
Intervention description: Health education mailings, 6 motivation interviews/counseling; Health education mailings, one motivation interview/counseling; Health education mailings; Buproprion or Nicotine Replacement Therapy
Intervention MeSH terms: Bupropion; Nicotine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 750.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary aim of this study is to assess the effectiveness of both high and low intensity,
      disease management programs for smoking. The hypotheses are to compare abstinence from
      cigarettes, the number of quit attempts, and smokers motivation at 24 months between
      participants receiving high and low intensity disease management and those receiving usual
      care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Over the age of 18

          -  Reported smoking at least 10 cigarettes per day for at least 25 of the last 30 days

          -  Speak English

          -  Their regular physician is a participating physician

          -  Working home telephone or cellular phone

        Exclusion Criteria:

          -  Women who are pregnant or planning to become pregnant in the next two years

          -  Plan on moving within two years

          -  Display signs of dementia or other mental disorders

          -  Live with a smoker already enrolled
Phase 3 Study Evaluating Safety and Efficacy of OTX-TP in Subjects With OAG or OHT
Condition: Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Travoprost; Placebo Vehicle
Intervention MeSH terms: Travoprost
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 565.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of the study is to evaluate evaluate the safety and IOP lowering efficacy of
      OTX-TP, a sustained release travoprost drug product, placed in the canaliculus of the eyelid
      in the treatment of subjects with open-angle glaucoma or ocular hypertension
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented diagnosis of ocular hypertension with an open angle of Schaffer Grade 3 or
             greater or open-angle glaucoma without pseudoexfoliation or pigment dispersion or
             evidence of traumatic angle recession

          -  IOP is currently controlled as assessed by the Investigator

        Exclusion Criteria:

          -  Punctum size smaller than 0.4 mm or greater than 0.9 mm in either eye as measured
             using a standard punctum gauge

          -  A history of an inadequate response or no response to topical prostaglandin

          -  Known or suspected allergy and/or hypersensitivity to travoprost or any prostaglandin,
             fluorescein, or to any component of the study products
Study to Evaluate the Safety and Efficacy of Adalimumab in Chinese Subjects With Moderate to Severe Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: adalimumab; placebo
Intervention description: subcutaneous injections of adalimumab; subcutaneous injections of placebo
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 205.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: China; Tumor necrosis factor (TNF)-alpha; Biologic

Summary:

      This study will evaluate the efficacy and safety of adalimumab induction and maintenance
      treatment in subjects with moderately to severely active Crohn's disease in China.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of Chinese descent with full Chinese parentage.

          -  Diagnosis of Crohn's disease (CD) for at least 3 months prior to Week 0.

          -  Crohn's Disease Activity Index (CDAI) greater than or equal to 220 and less than or
             equal to 450 despite treatment with oral corticosteroids and/or immunosuppressants.

          -  Subject has a negative Tuberculosis (TB) Screening Assessment.

          -  Subject has elevated high sensitivity C-reactive protein (hs-CRP) during the Screening
             Period.

        Exclusion Criteria:

          -  Subject with ulcerative colitis or indeterminate colitis.

          -  Subject who has had a surgical bowel resection within the past 6 months or who is
             planning any resection at any time point in the future.

          -  Subject with an ostomy or ileoanal pouch.

          -  Subject who has short bowel syndrome.

          -  Subject with symptomatic known obstructive strictures.

          -  Subject with an internal or external fistula (with the exception of an anal fistula
             without abscess).

          -  Active, or chronic or recurring infections, or active tuberculosis.
A Study Comparing LY900014 to Insulin Lispro (Humalog) in Children and Adolescents With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: LY900014; Insulin Lispro; Insulin Glargine; Insulin Degludec
Intervention description: Administered SC; Administered SC; Administered SC; Administered SC
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 751.0
Sex: All
Minimum age: 1 Year
Maximum age: 17 Years
Healthy volunteers: No
Keywords: prandial insulin; multiple daily injections; pediatric patients; postmeal dosing

Summary:

      The reason for this study is to compare the study drug LY900014 to insulin lispro (Humalog)
      in children and adolescents with type 1 diabetes (T1D).
    

Eligibility criteria:

        Inclusion Criteria:

          -  T1D for at least 6 months at the screening visit.

          -  Have been treated with only one of the following rapid-acting insulin analogs as part
             of an multiple daily injection regimen for at least the last 90 days prior to the
             screening visit:

               -  insulin lispro U-100, or

               -  insulin aspart

               -  insulin glulisine or

               -  fast acting insulin aspart

          -  Have been treated with only one of the following basal insulins for at least the last
             90 days prior to the screening visit:

               -  insulin glargine U-100 (once a day [QD] or twice a day [BID]), or

               -  insulin detemir U-100 (QD or BID), or

               -  insulin degludec U-100 (QD)

          -  Have a HbA1c value ≤ 9.9% at the screening visit.

        Exclusion Criteria:

          -  Have current hypoglycemic unawareness or have had more than 1 episode of severe
             hypoglycemia within 6 months prior to the screening visit.

          -  Have had more than 1 emergency room visit or hospitalization due to poor glucose
             control within 6 months prior to the screening visit.

          -  Have been on a treatment regimen that includes regular human insulin, neutral
             protamine Hagedorn (NPH), Afrezza® (insulin human) inhalation powder, any premixed
             insulins or use of diluted insulins within 90 days prior to the screening visit.
Efficacy of Secukinumab Compared to Adalimumab in Patients With Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Secukinumab; Adalimumab
Intervention description: Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio; Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 853.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriatic Arthritis; secukinumab; adalimumab; monoclonal antibody; CASPAR

Summary:

      This was a randomized, double-blind, active controlled, multicenter, parallel-group study
      evaluating secukinumab monotherapy and adalimumab monotherapy in approximately 850 patients
      with active psoriatic arthritis (PsA) who are naïve to biologic therapy and are intolerant or
      having inadequate response to conventional disease modifying anti-rheumatic drugs (also known
      as non-biologic DMARDs).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Diagnosis of PsA classified by CASPAR

          -  Rheumatoid factor and anti-CCP antibodies negative

          -  Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of >= 2cm
             diameter or nail changes consistent with psoriasis or documented history of plaque
             psoriasis

          -  Inadequate control of symptoms with NSAIDs

          -  Inadequate control of symptoms with a conventional DMARD.

        Key Exclusion Criteria:

          -  Pregnant or nursing women

          -  Evidence of ongoing infectious or malignant process

          -  Previous exposure to any biologic drug for Psoriatic Arthritis or Psoriasis

          -  Subjects taking high potency opioid analgesics

          -  Ongoing use of prohibited psoriasis treatments/medications

          -  Previous treatment with any cell-depleting therapies including but not limited to
             anti-CD20 investigational agents.