bioihbjkbjnl/mcl2 huggingface dataset:
LME636 in the Relief of Persistent Ocular Discomfort in Subjects With Severe Dry Eye Disease
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: LME636 ophthalmic solution; LME636 Vehicle
Intervention description: Inactive ingredients used as a placebo comparator
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 514.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: LME636; dry eye disease; efficacy; ocular discomfort

Summary:

      The purpose of this study is to evaluate the efficacy of LME636 compared to vehicle in the
      reduction of ocular symptoms and to evaluate the safety and tolerability of LME636, when
      administered topically for up to 42 days, in subjects with severe dry eye disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must sign written informed consent.

          -  Physician diagnosis of DED of at least 6 months prior to Visit 1.

          -  Must use artificial tears, gels, lubricants or re-wetting drops on a regular basis.

          -  Respond as "often" or "constantly" to the question "How often do your eyes feel
             uncomfortable?".

          -  Best Corrected Visual Acuity (BCVA) of 55 or greater in each eye as measured by ETDRS
             at Visit 1.

          -  Other protocol-specified inclusion criteria may apply.

        Exclusion Criteria:

          -  Presence of any acute infection or non-infectious ocular condition in either eye
             within 1 month of Visit 1.

          -  Contact lens wearers, defined as individuals who cannot be without their contact
             lenses for the entire duration of the study.

          -  Any chronic ocular degenerative condition that in the opinion of the Investigator
             could possibly advance during the time course of the study.

          -  Use of biologics treatments, such as systemic biologic anti-cytokines, including
             anti-TNFα drugs, or immunosuppressive therapy for the treatment of severe systemic
             autoimmune disorders.

          -  Diseases or conditions affecting the ocular surface that are associated with
             clinically significant scarring and or destruction of conjunctiva and/or cornea.

          -  Unwilling to abstain from topical ocular non-prescription medications during the
             course of the study, including concomitant use of artificial tears, gels, lubricants,
             re-wetting drops, allergy drops, etc. after Visit 2.

          -  Use of nasal, inhaled, systemic (including injections), or topical corticosteroids
             within 30 days of Visit 1.

          -  Women of child-bearing potential unwilling to use effective contraception methods as
             defined in the protocol.

          -  Other protocol-specified exclusion criteria may apply.
Efficacy and Safety Study of GED-0507-34-Levo for Treatment of UC
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: GED-0507-34-Levo 80 mg; GED-0507-34-Levo 160 mg; Placebo
Intervention description: GED-0507-34-Levo 80 mg BID for 8 Weeks; GED-0507-34-Levo 160 mg BID for 8 Weeks; Placebo BID for 8 Weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group
      study to evaluate the efficacy and safety of 2 doses of GED-0507-34-Levo in subjects with
      active, mild-to-moderate UC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged 18 and over at the time of signing the informed consent.

          -  Diagnosis of UC with a duration of at least 3 months prior to the Screening Visit.

          -  MMS ≥ 4 to ≤ 8 (range: 0 - 9) prior to randomization in the study

          -  Subjects are required to have a colonoscopy if one has not been performed within 12
             months prior to the Screening Visit.

          -  Subjects who have relapsed on maintenance therapy with doses of 5-ASA ≤ 2.4 g/day

        Exclusion Criteria:

          -  Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, microscopic
             colitis, radiation colitis, or diverticular disease-associated colitis.

          -  UC restricted to the distal 15 cm or less (eg, ulcerative proctitis).

          -  Subjects who have had surgery as a treatment for UC or who, in the opinion of the
             Investigator, are likely to require surgery for UC during the study.

          -  Clinical signs suggestive of fulminant colitis or toxic megacolon.

          -  Evidence of pathogenic enteric infection.

          -  History of colorectal cancer or colorectal dysplasia.

          -  Prior use of any TNF inhibitor (or any biologic agent).

          -  Prior use of mycophenolic acid, tacrolimus, sirolimus, cyclosporine, or thalidomide.

          -  Use of budesonide-MMx within the last 8 weeks.

          -  Use of oral and/or IV corticosteroids within 2 weeks of the Screening Visit.

          -  Use of immunosuppressants (azathioprine [AZA], 6-mercaptopurine [6-MP] or methotrexate
             [MTX]) within 8 weeks of the Screening Visit.
Clinical Trial of Intravitreal Microplasmin in Infants and Children Scheduled for Vitrectomy
Condition: Vitrectomy
Intervention: Ocriplasmin; Placebo
Intervention description: 175µg ocriplasmin intravitreal injection; Placebo intravitreal injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 24.0
Sex: All
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Safety in pediatrics

Summary:

      To evaluate the safety and preliminary efficacy of intravitreal microplasmin as an adjunct to
      conventional vitrectomy for the treatment of pediatric patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female infants or children 16 years of age or younger

          2. Patient must be a suitable candidate for conventional 2-port or 3-port pars plana
             vitrectomy

          3. Patient with attached vitreous somewhere in posterior pole

          4. Patient's parent or guardian must be willing and able to comply with follow-up
             requirements

          5. Patient's parent(s) must sign informed parental permission form and in the case of
             school-age children the patient must sign assent form

        Exclusion Criteria:

          1. Patient diagnosed with Stage 1, 2, 3 or 5 retinopathy of prematurity (ROP) at the time
             of surgery

          2. Unclear media, which precludes assessment of the posterior pole such as a cataract or
             vitreal opacity

          3. Active parental/guardian drug or alcohol use or dependence that, in the opinion of the
             site Investigator, would interfere with parent's or guardian's adherence to study
             requirements

          4. Medical problems that make consistent follow-up over the treatment period uncertain.

          5. Patient must not have participated in an investigational drug or device study in the
             prior 30 days

          6. Female Patients of childbearing potential must not be pregnant or lactating.
A 12-Week Safety and Pharmacodynamic Study of AT1001 (Migalastat Hydrochloride) in Participants With Fabry Disease
Condition: Fabry Disease
MeSH terms: Fabry Disease
Intervention: migalastat HCl
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Amicus Therapeutics; AT1001; Galafold; Migalastat; Substrate

Summary:

      Study to evaluate the safety, tolerability, and pharmacodynamics of migalastat hydrochloride
      (HCl) (migalastat) and how migalastat works in participants with Fabry disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males between 18 and 65 years of age (inclusive)

          -  Hemizygous for Fabry disease

          -  Had a confirmed diagnosis of Fabry disease with a documented missense gene mutation
             (individual or familial)

          -  Had enhanceable enzyme activity based on in vitro tests

          -  Had documented evidence of cardiac and/or renal dysfunction (for example, abnormal
             electrocardiogram (ECG), left ventricular hypertrophy, renal insufficiency) and/or
             cerebral tissue dysfunction documented by evidence of stroke and/or peripheral nervous
             tissue dysfunction (for example, intolerance to heat/cold, decrease of perspiration)

          -  Must have been previously untreated by enzyme replacement therapy (ERT) or substrate
             depletion for Fabry disease or were able to stop ERT for at least 18 weeks or up to
             three months, and be willing to undergo two kidney and three skin biopsies

          -  Agreed to be sexually abstinent or use a condom with spermicide when engaging in
             sexual activity during the course of the study and for a period of 30 days following
             their completion of the study

          -  Were willing and able to sign an informed consent form

        Exclusion Criteria:

          -  History of significant disease other than Fabry disease

          -  History of organ transplant

          -  Serum creatinine >2 mg per deciliter on Day -2

          -  Screening 12-lead ECG demonstrating corrected QT interval >450 milliseconds prior to
             dosing

          -  Pacemaker or other contraindication for magnetic resonance imaging (MRI) scanning

          -  Took any of the following prohibited medications: Fabrazyme® (agalsidase beta),
             Replagal™ (agalsidase alfa), Glyset® (miglitol), Zavesca® (miglustat), or any
             experimental therapy for any indication

          -  Participated in a previous clinical trial in the last 30 days

          -  Any other condition, which, in the opinion of the investigator, would jeopardize the
             safety of the participant or impact the validity of the study results
Efficacy and Safety of AlphaNine Versus BeneFIX in Patients With Severe Hereditary Haemophilia B
Condition: Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Intervention: BeneFIX
Intervention description: BeneFIX is a recombinant FIX that contains nonacog alfa, reconstituted in solvent and administered as a single dose of 65-75 IU/kg.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Factor IX (FIX)

Summary:

      The goal of this non-randomized, multi-center study in subjects with severe hereditary
      haemophilia B was to determine and compare the pharmacokinetic and safety profiles of BeneFIX
      in subjects having had 2 prior pharmacokinetic assessments with AlphaNine.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Participated in the previous study "Efficacy and safety of factor IX (FIX) contained
             in Alphananine in patients with severe hereditary haemophilia B":

          -  Congenital deficiency in Factor IX (FIX)

          -  FIX residual activity of ≤2% of normal

          -  Had required FIX-containing products in the past and in clinical records that were
             collected data to assess a reliable estimation of at least 150 treatment exposure days
             to previous products

          -  Was able to receive treatment for more than 10 days for a 6-month period

        Key Exclusion Criteria:

          -  Received a dose of FIX in the 7 days prior to the infusion

          -  FIX inhibitor level of >0.5 Bethesda units (BU) or clinically relevant presence in the
             past (≥5 BU)

          -  Active bleeding at the moment of infusion

          -  Had a known allergic reaction to any BeneFIX component

          -  Exhibited symptoms of any intercurrent infection (ie, fever, chills, nausea) at the
             time of the first infusion

          -  Had any disease that might affect the distribution or metabolism of FIX and which
             could affect interpretation of the study (such as non-controlled diabetes mellitus)

          -  Had non-controlled arterial hypertension

          -  Had abnormal renal function (creatinine >1.5 mg/dL)

          -  Had documented liver cirrhosis or any hepatic disorder with alanine aminotransferase
             (ALT) levels 2.5x upper limit of normal (ULN )

          -  Prevision to be concomitantly treated with other FIX-containing products

          -  Had conditions that might affect subject compliance (survival-limiting [in 2 year
             time] diseases, alcohol or other drug abuse, etc.)

          -  Unable to provide a storage plasma sample before the first dose of BeneFIX
Acute Effects of Inorganic Nitrite on Cardiovascular Hemodynamics in Heart Failure With Preserved Ejection Fraction
Condition: Heart Disease; Heart Failure With Preserved Ejection Fraction; Exercise Intolerance; Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Heart Failure; Heart Diseases
Intervention: Nitrite; Saline Placebo for Nitrite
Intervention description: Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.; Normal saline placebo will be infused for 5 minutes during the cardiac catheterization procedure. Hemodynamics will then be measured at baseline after study drug infusion and again during low level exercise (20 Watts).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Heart failure with preserved ejection fraction (HFpEF) is a major public health problem that
      has no proven effective treatment. This study assessed the effects of acute nitrite
      administration on resting and exercise hemodynamics in patients with HFpEF.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Scheduled to undergo a cardiac catheterization procedure.

          -  Clinical symptoms of shortness of breath and fatigue

          -  Normal left ventricular ejection fraction (≥50%)

          -  Elevated left ventricular filling pressures at cardiac catheterization (defined as
             resting pulmonary capillary wedge pressure (PCWP)>15 mmHg and/or PCWP≥25 mmHg during
             exercise)

        Exclusion Criteria:

          -  Systolic BP <120 mmHg

          -  Prior nitrate therapy (within previous 2 weeks)

          -  Glucose 6-phosphate dehydrogenase (G6PD) deficiency

          -  Other "non-HFpEF" specific causes of heart failure such as significant valvular
             disease (>moderate left-sided regurgitation, >mild stenosis), severe pulmonary
             disease, unstable coronary disease or coronary spasm, primary renal or hepatic
             disease, constrictive pericarditis, or infiltrative, restrictive, or hypertrophic
             cardiomyopathies
A Phase II Study to Evaluate the Efficacy of TKI258 for the Treatment of Patients With FGFR2 Mutated or Wild-type Advanced and/or Metastatic Endometrial Cancer
Condition: Solid Tumors and Advanced Endometrial Cancer; Endometrial Cancer; Second-line Treatment; VEGF
MeSH terms: Endometrial Neoplasms
Intervention: TKI258
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Solid tumors,; advanced endometrial cancer,; Endometrial Cancer,; Second-line treatment,; VEGF,; Neoplasms,; Endometrial Neoplasms,; Uterine Neoplasms,; Female Genital Neoplasms,; Cancer,; Carcinoma,; Uterine Diseases,; Female Genital Diseases,; Tumors,; Oral Administration,; Capsules,; Tablets,; CHIR258,; CHIR-258,; CHIR 258,; TKI258,; TKI-258,; TKI 258

Summary:

      This is a prospective, multi-center, open-label, single-arm, non-randomized, Phase II study
      to evaluate the efficacy and safety of TKI258 as second-line therapy in patients with either
      FGFR2 mutated or wild-type advanced and/or metastatic endometrial cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with histologically confirmed diagnosis of advanced and/or metastatic
             endometrial cancer with available tissue specimen (either archival tissue or fixed
             fresh biopsy)

          -  Female patients ≥ 18 years old

          -  Documented radiologically confirmed progression of disease after prior first-line
             treatment evidence of progressive disease

          -  ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2

          -  At least one measurable lesion as per RECIST

        Exclusion Criteria:

          -  Previous treatment with an FGFR inhibitor

          -  More than one line of treatment for advanced or metastatic disease

          -  Patients with uterine sarcomas, adenosarcoma, and malignant Mullerian tumors

          -  Patients with isolated recurrences (vaginal, pelvic, or para-aortic) potentially
             curative with radiation therapy or surgery

          -  Known central nervous system (CNS) metastases

          -  Malignancy within 3 years of study enrollment Other protocol-defined
             inclusion/exclusion criteria may apply
Treatment of Multiple System Atrophy Using Intravenous Immunoglobulins
Condition: Multiple System Atrophy
MeSH terms: Multiple System Atrophy; Shy-Drager Syndrome; Atrophy
Intervention: intravenous immunoglobulin (IVIg)
Intervention description: The intravenous immunoglobulin (brand Privigen) will be infused intravenously, monthly, 6 times, for 6 months the dose will be 0.4 gram/kg for each infusion.
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies; gamma-Globulins; Rho(D) Immune Globulin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: multiple system atrophy, MSA,; intravenous immunoglobulin, IVIg

Summary:

      Multiple System Atrophy (MSA) is a progressive sporadic neurodegenerative disorder leading to
      widespread loss of brain cells that results in parkinsonian, cerebellar and autonomic
      dysfunction. The cause of the MSA remains unclear. Available treatment is symptomatic only
      and does not alter the course of disease.

      Although the cause of MSA remains unclear, there is evidence of presence of common
      neuroinflammatory mechanisms in the MSA brains including activation of microglia and
      production of toxic cytokines. This research protocol is based on hypothesis that the MSA
      progression can be altered by blocking the neuroinflammatory activity.

      This protocol includes administration of intravenous immunoglobulin (IVIg). IVIg contains
      antibodies derived from human plasma which can block the inflammatory responses in the brain
      that can lead to loss of brain cells.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female older than 17 years.

          2. Clinical diagnosis of probable multiple system atrophy

          3. Provide written informed consent to participate in the study

          4. Understand that they may withdraw their consent at any time

        Exclusion Criteria:

          1. Women who are pregnant or lactating

          2. In the investigator's opinion, have any other significant systemic, hepatic, cardiac
             or renal illness.

          3. In the investigator's opinion, the subjects are significantly dehydrated, as
             determined by clinical evaluation including measurement of skin turgor, blood urea
             nitrogen and creatinine values.
Study of the Effectiveness of Quetiapine for the Treatment of Alcohol Dependency
Condition: Alcoholism; Alcohol Abuse
MeSH terms: Alcoholism
Intervention: Quetiapine fumarate; Placebo
Intervention description: Quetiapine fumarate- taken daily, for 12 weeks; Placebo
Intervention MeSH terms: Quetiapine Fumarate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 224.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Alcoholism; Alcohol dependence; Quetiapine

Summary:

      The purpose of this study is to determine whether quetiapine fumarate extended release is
      effective in the treatment of alcohol dependence in very heavy drinkers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between the ages of 18 and 65 years old

          -  DSM-IV diagnosis of current alcohol dependence as supported by SCID Module E

          -  Report "very heavy" drinking (10 or more drinks per drinking day for men or 8 or more
             drinks per drinking day for women) at least 40% of the days during the interval from
             day 31 to 90 prior to the initial screening visit (i.e. a total of 24 days of this
             60-day period), with at least one day of "very heavy" drinking occurring within the
             last 2 weeks before screening

          -  Seeking treatment for alcohol dependence and desire reduction or cessation of drinking

          -  Able to verbalize understanding of the consent form, able to provide written informed
             consent, and verbalize willingness to complete study procedures

          -  Females of child bearing potential must agree to use of at least one approved method
             of birth control, or must be surgically sterile or postmenopausal

          -  Able to take oral medication, willing to adhere to the medication regimen, and willing
             to return for regular visits

          -  Able to understand written and oral instructions in English and to complete the
             questionnaires required by the protocol

          -  Can complete all psychological assessments required at screening and baseline

          -  Able to provide evidence of stable residence in the last 2 months prior to
             randomization, have reasonable transportation arrangements to study site, and have no
             plans to move within the next 3 months or unresolved legal problems; must provide
             contact information of family member, spouse, or significant other who can contact
             subject in case of missed appointment

          -  Breath alcohol concentration (BAC) equal to 0.00 when s/he signed the informed consent
             document

          -  Must have an absolute neutrophil count of 1.5 x 109/L or greater.

        Exclusion Criteria:

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