bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of AZR-MD-001 in Patients With Meibomian Gland Dysfunction (MGD)
Condition: Meibomian Gland Dysfunction
MeSH terms: Meibomian Gland Dysfunction
Intervention: AZR-MD-001 Active; AZR-MD-001 Vehicle
Intervention description: AZR-MD-001 is an active ophthalmic ointment; AZR-MD-001 is a vehicle ophthalmic ointment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      AZ202001 is a multicenter study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients
      with Meibomian Gland Dysfunction (MGD)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female

          -  18 years of age or older

          -  Best-corrected visual acuity (BCVA) of 20/40 or better (Snellen equivalent), using the
             logarithm of the minimum angle of resolution (LogMAR) in each eye

          -  Evidence of meibomian gland obstruction

          -  Reported dry eye signs and symptoms within the past 3 months

        Exclusion Criteria:

          -  Uncontrolled ocular disease (except for MGD and dry eye disease/keratoconjunctivitis
             sicca) or uncontrolled systemic disease

          -  Glaucoma, ocular hypertension, or intraocular pressure (IOP) in either eye at
             screening ≥24 mm Hg or has planned insertion/removal of glaucoma filtration
             shunts/devices during the study

          -  Corneal abnormality or disorder that impacts normal spreading of the tear film or
             corneal integrity

          -  BCVA worse than 20/40 in either eye

          -  Current use of punctal plugs, anticipated insertion during the study, or a history of
             punctal cautery in either eye
N-Acetyl Cysteine Plus Behavioral Therapy for Nicotine Dependent Pathological Gamblers
Condition: Gambling; Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder; Gambling
Intervention: N Acetyl Cysteine; Sugar Pill
Intervention description: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks; placebo control
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: N acetyl cysteine; Pathological gambling; Nicotine dependence

Summary:

      The objective of this application is to examine whether, given its mechanism of action, the
      dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and pathological
      gamblers (PG) symptoms in nicotine dependent pathological gamblers.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female outpatients, age 18-75 years;

          2. Presence of current DSM-IV nicotine dependence and PG for at least 6 months duration;

          3. Stable psychotropic drug dose for a period of at least 3 months prior to study entry;

          4. Completion of complete blood count, urinalysis, liver function tests, thyroid function
             tests, and pregnancy test with no evidence of significant lab abnormalities;

          5. Signed informed consent

        Exclusion Criteria:

          1. Subjects who are currently receiving individual or group therapy specifically for
             nicotine dependence or PG symptoms;

          2. Currently receiving pharmacotherapies for either nicotine dependence or pathological
             gambling;

          3. Subjects who have started attending Gamblers Anonymous within the 3 months prior to
             study initiation;

          4. Subjects who have an unstable and significant medical illness;

          5. Current clinically significant suicidality (score or 3 or 4 on item 3 of the Hamilton
             Depression Rating Scale) or any other disorder requiring immediate intervention;

          6. Lifetime history of bipolar disorder type I or II, dementia, or psychotic disorder;

          7. Current (past 12 months) DSM-IV substance abuse or dependence (except nicotine
             dependence);

          8. Borderline or antisocial personality disorder based on the SCID-II;

          9. Positive urine drug screen at screening;

         10. Asthma (given possible worsening of asthma due to NAC);

         11. Cognitive impairment that interferes with the capacity to understand and
             self-administer medication or provide written informed consent;

         12. Current pregnancy or lactation, or inadequate contraception in women of childbearing
             potential; and

         13. Previous treatment with NAC
A Randomized Trial of CT Fluoroscopy-guided Targeted Autologous Blood and Fibrin Glue Patching for Treatment
Condition: Cerebrospinal Fluid Leaks
MeSH terms: Cerebrospinal Fluid Leak; Intracranial Hypotension
Intervention: TISSEEL
Intervention description: TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients (>1 month of age) undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients
Intervention MeSH terms: Fibrin Tissue Adhesive
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CT fluoroscopy; epidural patching; spontaneous intracranial hypotension

Summary:

      The goal of this randomized controlled trial (RCT) is to compare the efficacy of CT
      fluoroscopy-guided targeted epidural patching for treatment of imaging-confirmed spinal CSF
      leaks to that of a simulated procedure without patching material in patients with spontaneous
      intracranial hypotension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients meeting International Classification of Headache Disorders 3rd Edition
             (ICHD-3) criteria for a diagnosis of SIH (Table 1) who have had a contrast-enhanced
             brain MRI and a myelogram confirming the presence of a CSF leak will be recruited from
             the Duke Radiology spine intervention clinic [25]

        Exclusion Criteria:

          -  recent (i.e., < 2 weeks) blood patch

          -  contraindication or inability to undergo the procedure

          -  inability to provide informed consent

          -  expected inability to complete follow-up assessment

          -  a contraindication to receiving contrast material (precluding an epidurogram)

          -  contraindication to receiving fibrin glue (i.e., allergy).
Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis
Condition: Detrusor Muscle Hyperactivity
MeSH terms: Multiple Sclerosis; Spinal Cord Injuries
Intervention: Botulinum toxin type A; Placebo
Intervention description: 750 U intra detrusor injection on Day 1 (single dose); Intra detrusor injection on Day 1 (single dose)
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Detrusor Muscle Overactivity

Summary:

      The purpose of this study is to determine the efficacy and safety of a single dose of 750 U
      of Dysport compared to placebo for the improvement in the daily incontinence episode
      frequency for each administration mode in subjects suffering from neurogenic detrusor
      overactivity following spinal cord injury or multiple sclerosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject, family member or care giver was willing and able to perform clean
             intermittent catheterisation (CIC) for the duration of the study

          -  Inadequate response or refractory to anticholinergic medication

          -  Botulinum Toxin naive for intradetrusor injections and with no previous treatment with
             Botulinum Toxin of any type, within 3 months prior to study entry for any other
             condition

          -  Have a minimum of 2 incontinences per day calculated as the average daily incontinence
             episode frequency (IEF) over the 3 days preceding the baseline visit

        Exclusion Criteria:

          -  Significant Baseline renal and/or urinary tract pathology

          -  Previous treatment with any endovesical pharmacology agent including detrusor
             Botulinum Toxin injection
Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic Dermatitis
Condition: Pruritus; Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Pruritus
Intervention: Serlopitant High Dose; Placebo Oral Tablet; Serlopitant Low Dose
Intervention description: serlopitant tablets - high dose; placebo tablet; serlopitant tablets - low dose
Intervention MeSH terms: Serlopitant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 484.0
Sex: All
Minimum age: 13 Years
Healthy volunteers: No

Summary:

      Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic
      Dermatitis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age 13 years or older

          -  Pruritus prior to and during the initial screening period

          -  Diagnosis of atopic dermatitis

          -  Judged to be in good health in the investigator's opinion

        Exclusion Criteria:

          -  Prior treatment with study drug or similar drug

          -  Pruritus due to another reason besides atopic dermatitis

          -  Presence of any medical condition or disability that could interfere with study

          -  History of hypersensitivity to serlopitant or any of its components

          -  Currently pregnant or male partner of pregnant female

          -  Females of childbearing potential who are unable or unwilling to use adequate
             contraception or who are breast feeding
A Study to Investigate Effects of Omega-3 Carboxylic Acids and Dapagliflozin on Liver Fat Content in Diabetic Patients
Condition: T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin)
MeSH terms: Liver Diseases; Fatty Liver
Intervention: placebo; Omega-3 carboxylic acids; Dapagliflozin; Placebo
Intervention description: Placebo matching to Omega-3 carboxylic acids (olive oil); 4 g administered as 4 x 1 g capsules; 10 mg administered as 10 mg tablet; Placebo matching to dapagliflozin 10 mg
Intervention MeSH terms: Dapagliflozin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 223.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: omega-3 carboxylic acid

Summary:

      This study is a double-blind randomized, placebo-controlled, parallel-group, 12 week study
      performed in up to 5 centres in Sweden to assess the effect of Omega-3 carboxylic acids and
      dapagliflozin on liver fat in patients with Type 2 diabetes with fatty liver (>5.5% as
      measured with magnetic resonance imaging (MRI))
    

Eligibility criteria:

        Inclusion Criteria: Provision of informed consent prior to any study specific procedures;
        Men or women ≥40 years and ≤75 years with suitable veins for cannulation or repeated
        venepuncture; Have liver fat content as assessed by MRI >5.5%; Diagnosis of Type 2 diabetes
        since at least 6 months in accordance with WHO criteria.

        Exclusion Criteria: Any condition when MRI is contraindicated such as, but not limited to,
        having a pacemaker or claustrophobia; Diagnosis or signs of Type 1 diabetes (e.g. history
        of positive islet antibodies); Creatinine clearance <60 mL/min at screening
        (Cockcroft-Gault formula).
Ofatumumab and Bendamustine for Previously Treated Chronic Lymphocytic Leukemia (CLL)
Condition: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Ofatumumab and Bendamustine
Intervention description: Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles
Intervention MeSH terms: Bendamustine Hydrochloride; Ofatumumab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CLL; SLL; Bendamustine; Ofatumumab

Summary:

      The purpose of this study is to evaluate the safety and effectiveness of the combination of
      bendamustine and ofatumumab in subjects with relapsed/refractory chronic lymphocytic leukemia
      and small cell lymphoma. All subjects enrolled on this study will receive both drugs by
      intravenous (IV) infusion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically confirmed CLL or SLL requiring therapy

          -  Age 18 years of age or older

          -  ECOG performance status 0, 1, or 2

          -  Normal organ and bone marrow function

          -  Resolution of toxic effects from prior therapies

          -  Ability to adhere to the study schedule and give written informed consent

        Exclusion Criteria:

          -  Any serious medical, psychiatric illness or laboratory abnormality

          -  Chemotherapy or radiotherapy within 4 weeks of entering the study

          -  Currently receiving other treatment for CLL/SLL or other malignancies

          -  Active other malignancies

          -  History of allergic reactions to bendamustine or ofatumumab

          -  Ongoing corticosteroid use

          -  Pregnant or lactating

          -  HIV positive

          -  Active hepatitis B

          -  Allogeneic transplant within 6 months of entering study or graft-versus-host disease.
Dose Response Study of EMA401 in Patients With Post-herpetic Neuralgia (PHN)
Condition: Post-herpetic Neuralgia
MeSH terms: Neuralgia; Neuralgia, Postherpetic
Intervention: EMA401; Placebo
Intervention description: EMA401; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: post-herpetic neuralgia; neuropathic pain; angiotensin II type 2 receptor antagonist; dose ranging

Summary:

      This study was designed to characterize dose response, and evaluate safety and efficacy of
      three different doses of EMA401 compared to placebo in patients with post-herpetic neuralgia
      (PHN).
    

Eligibility criteria:

        Inclusion Criteria:

          -  At the time of Screening, must have had documented diagnosis of PHN (ICD-10 code
             B02.29), defined as pain in the region of the rash persisting for more than 6 months
             after onset of herpes zoster rash.

          -  Assessed as suffering from moderate to severe neuropathic pain across the Screening
             epoch (NRS ≥ 4).

          -  Patients must have had documented past and/or ongoing inadequate treatment response
             (having insufficient pain relief with treatment or inability to tolerate) to at least
             2 different prescribed therapies commonly used to treat and considered effective by
             the Investigator for the treatment of PHN.

          -  Patient must have been willing to complete daily eDiary

        Exclusion Criteria:

          -  History or had current diagnosis of electrocardiogram (ECG) abnormalities indicating
             significant risk of safety for patients participating in the study

          -  Had a major depressive episode within 6 months prior to Screening and/or a history of
             diagnosed recurrent major depressive disorder according to Diagnostic and Statistical
             Manual of Mental Disorders, 5th Edition (DSM-V) diagnostic criteria

          -  Women of child-bearing potential, defined as all women physiologically capable of
             becoming pregnant.

          -  Had evidence of significant renal insufficiency or pre-existing liver condition

          -  Had platelets ≤ 100 x 10^9/L, or neutrophil count < 1.2 x 10^9/L (or equivalent),
             hemoglobin ≤ 100 g/L for women or hemoglobin ≤ 110 g/L for men.

          -  Patients who had a known diagnosis of diabetes and are stable on medication with a
             hemoglobin A1c > 8%. Those who did not have a known diagnosis of diabetes with a
             hemoglobin A1c > 7%.
Efficacy and Tolerability Study of Two Dose Regimens of CTP-543 in Adults With Alopecia Areata
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Intervention: CTP-543; CTP-543 Matching Placebo
Intervention description: CTP-543 administered as 8 mg tablet.; Administered as tablets to aid treatment masking.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and tolerability of once-daily versus twice-daily
      dosing of CTP-543, in adult patients with chronic, moderate to severe alopecia areata.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Definitive diagnosis of alopecia areata with a current episode lasting at least 6
             months and not exceeding 10 years at the time of Screening. Total disease duration
             greater than 10 years is permitted.

          -  At least 50% scalp hair loss, as defined by a Severity of Alopecia Tool (SALT) score
             ≥50, at Screening and Baseline.

          -  Clinical lab results within the normal range

        Exclusion Criteria:

          -  Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical
             treatment to the scalp, significant trauma to the scalp, or untreated actinic
             keratosis on the scalp.

          -  Treatment with systemic immunosuppressive medications or biologics.

          -  Vaccination with herpes zoster vaccine or any live virus within 6 weeks of screening
             or during the study
A Study of Multiple Oral Doses of JNJ-41443532 in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: JNJ-41443532; Pioglitazone 30 mg; Placebo
Intervention description: Participants will receive JNJ-41443532 tablet(s) orally in JNJ-41443532 250 mg arm (1 X 250 mg) and JNJ-41443532 1000 mg arm (4 X 250 mg) in morning and evening, for 28 days.; Participants will receive tablet pioglitazone 30 mg orally in morning for 28 days.; Participants will receive matching placebo tablets of JNJ-41443532 and/or matching placebo tablets of pioglitazone orally as per the assigned arms.
Intervention MeSH terms: Pioglitazone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 89.0
Sex: All
Minimum age: 25 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus, Type 2; Diabetes Mellitus; Hyperglycemia; JNJ-41443532; Pioglitazone; Placebo

Summary:

      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (what the
      body does to the medication) and pharmacodynamics (what the medication does to the body) of
      treatment with JNJ-41443532 relative to treatment with placebo in type 2 diabetes mellitus
      participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed Type 2 Diabetes Mellitus (T2DM) for at least 3 months prior screening

          -  On a stable treatment regimen for at least 2 months prior screening

          -  Medically stable on the basis of physical examination, medical history, and clinical
             laboratory tests performed at screening and 2 days before administration of the study
             medication

          -  Fasting plasma glucose (FPG) concentrations between 140 mg/dL and 270 mg/dL on 2 days
             before administration of the study medication

          -  Agrees to protocol-defined use of effective contraception

        Exclusion Criteria:

          -  History of other types of diabetes and complications or secondary forms of diabetes

          -  History of eating disorder or recent significant changes in body weight (ie, more or
             equal to 5 percent over 3 months prior to screening) due to dieting or nutritional
             treatments

          -  Taking antihyperglycemic agents (insulin, exenatide, and liraglutide) within 6 months
             or thiazolidinedione within 3 months of 2 days before administration of the study
             medication

          -  Clinically significant abnormal electrocardiogram

          -  History of, or currently active, significant illness or medical disorders, retinal
             disease, tuberculosis

          -  Clinically important serious infection, positive for serology at screening (hepatitis
             B surface antigen, hepatitis C antibodies or human immunodeficiency virus antibodies)