bioihbjkbjnl/mcl2 huggingface dataset:
A 24 Month Phase 2a Open Label, Randomized Study of Avastin®, Lucentis®, or Eylea® (Anti-VEGF Therapy) Administered in Combination With Fovista® (Anti-PDGF BB Pegylated Aptamer)
Condition: Age-Related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Fovista®; bevacizumab; ranibizumab; aflibercept
Intervention MeSH terms: Bevacizumab; Ranibizumab; Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Wet AMD; subfoveal choroidal neovascularization; Fovista®; Avastin®; Lucentis®; Eylea®

Summary:

      To evaluate the safety of intravitreal (IVT) Fovista® administered in combination with
      anti-VEGF therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of either gender aged ≥ 50 years.

          -  Active subfoveal choroidal neovascularization (CNV) due to AMD.

        Exclusion Criteria:

          -  Any intraocular surgery or thermal laser within three (3) months of trial entry. Any
             prior thermal laser in the macular region, regardless of indication.

          -  Subjects with subfoveal scar or subfoveal atrophy

          -  Any ocular or periocular infection in the past twelve (12) weeks.

          -  History of any of the following conditions or procedures in the study eye:
             Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g.
             trabeculectomy), glaucoma drainage device, corneal transplant.
A Phase II Trial of 18F-AV-45 Positron Emission Tomography (PET) Imaging in Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)
Condition: Alzheimer's Disease; Mild Cognitive Impairment
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Intervention: florbetapir F 18
Intervention description: IV injection, 370MBq (10mCi), single dose
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 184.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Evaluate 18F-AV-45 positron emission tomography (PET) imaging for distinguishing healthy
      control subjects, from subjects with Alzheimer's disease (AD) or Mild cognitive impairment
      (MCI).
    

Eligibility criteria:

        Inclusion Criteria AD:

          -  Male or female >=50 years of age

          -  Meet National Institute of Neurological and Communicative Diseases and
             Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS) criteria for
             probable AD with MMSE score of 10-24

        Inclusion Criteria MCI:

          -  Male or female >=50 years of age

          -  Have a Clinical Dementia Rating (CDR) of 0.5

          -  MMSE >24

        Normal subjects:

          -  Male or female >=50 years of age

          -  MMSE >=29

          -  Normal on psychometric test battery at screening

          -  Provide informed consent

        Exclusion Criteria:

          -  Have a history or current diagnosis of other neurologic disease

          -  Have had or currently have a diagnosis of other neurodegenerative disease

          -  Have participated in experimental therapy targeted to amyloid plaque
The CHARM Trial: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts
Condition: Mucinous Pancreatic Cysts
MeSH terms: Pancreatic Cyst
Intervention: Ethanol; Normal Saline; Chemotherapy
Intervention description: Cysts will be lavaged for 3-5 minutes with 80% EtOH; Cysts will be lavaged for 3-5 minutes with normal saline; Following lavage with either 80% ethanol (control group) or normal saline (study group), cysts will be injected with a cocktail of 3mg/ml paclitaxel and 19mg/ml gemcitabine.
Intervention MeSH terms: Ethanol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pancreatic cyst; chemotherapy; ethanol; ablation

Summary:

      The purpose of this study is to evaluate the efficacy of a chemotherapeutic cocktail with or
      without prior ethanol lavage for ablation of premalignant pancreatic cysts using endoscopic
      ultrasound-guided fine needle injection (EUS-FNI) for agent delivery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients age 18 and older of any gender, ethnicity and race

          -  Voluntary enrollment and ability to give written informed consent

          -  Capable of safely undergoing endoscopy with deep sedation or general anesthesia

          -  Patients with previously-detected pancreatic cyst(s) 1-5 cm in diameter, including
             indeterminate cysts

        Exclusion Criteria:

          -  Pancreatic cyst <1cm or >5cm

          -  Pancreatic cyst with clear communication with main pancreatic duct

          -  Clearly benign lesions by clinical and radiographic evaluation (pseudocysts and serous
             cystadenomas)

          -  Known or suspected pancreatic cancer or pathologic lymphadenopathy

          -  Septated cysts with > 5 compartments

          -  Coagulopathy (international normalized ratio > 1.6, platelets < 30,000)

          -  Evidence of active pancreatitis or pancreatic infection

          -  Patients having undergone endoscopic retrograde cholangiopancreatography (ERCP) within
             72 hours

          -  Baseline lab values at the time of consent: white blood cells > 14 or < 2, hematocrit
             < 30, platelets < 30,000, INR > 1.6, abnormal CA19-9, lipase > 3 times the upper limit
             of normal, creatinine > 2.5, ALT > 210, total bilirubin > 2.5, positive qualitative
             beta-hCG.

          -  Any pre-existing or discovered medical condition that may, at the discretion of the
             investigator, interfere with the completion of and/or participation in the existing
             protocol.

          -  Pregnant, breastfeeding, or incarcerated individuals
A Pilot Study Of A Novel Treatment Regimen, Maraviroc + Ritonavir Boosted Atazanavir, In Treatment Naive HIV-Infected Patients
Condition: Human Immunodeficiency Virus-1
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Intervention: maraviroc; maraviroc
Intervention description: maraviroc (Selzentry, Celsentri) 150mg QD + atazanavir (Reyataz) /ritonavir (Norvir) (300/100mg) QD OR maraviroc (Selzentry, Celsentri) 150mg QD+ darunavir (Prezista)/ritonavir (Norvir) (800/100 mg) QD (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by darunavir (Prezista)/ritonavir (Norvir)) OR maraviroc (Selzentry, Celsentri) 150mg QD+ lopinavir/ritonavir (Kaletra, Aluvia) (400/100 mg) BID (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by lopinavir/ritonavir (Kaletra, Aluvia)); emtricitabine/tenofovir (Truvada) 200/300mg QD + atazanavir (Reyataz) /ritonavir (Norvir) 300/100 mg QD OR emtricitabine/tenofovir (Truvada) 200/300 mg QD + darunavir (Prezista)/ritonavir (Norvir) (800/100 mg) QD (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by darunavir (Prezista)/ritonavir (Norvir)) OR emtricitabine/tenofovir (Truvada) 200/300 mg QD + lopinavir/ritonavir(Kaletra, Aluvia) (400/100 mg) BID (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by lopinavir/ritonavir (Kaletra, Aluvia))
Intervention MeSH terms: Ritonavir; Lopinavir; Atazanavir Sulfate; Darunavir; Tenofovir; Emtricitabine; Maraviroc
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 129.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: CCR5-tropic HIV-1 virus

Summary:

      This is a pilot study to examine if the novel treatment regimen maraviroc plus boosted
      atazanavir can be expected to be safe and efficacious in treatment naive HIV infected
      patients. Based on the results from this study, a confirmatory phase 3 study may be
      conducted.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1 RNA viral load of ≥1,000 copies/mL measured at the Screening Visit.

          -  CD4 count ≥100 cells/mm3 at Screening.

          -  Have only R5 HIV-1 at Screening as verified by the Monogram Bioscience Trofile® assay
             with enhanced sensitivity.

        Exclusion Criteria:

          -  Prior treatment with any other HIV antiretroviral therapy for more than 14 days at any
             time.

          -  Any evidence of resistance to atazanavir, tenofovir, and emtricitabine.

          -  X4-or dual/mixed-tropic virus by enhanced Trofile assay or repeated assay failure or
             not reportable results.
Study Evaluating TheSafety And Efficacy Of PF-05212377 Or Placebo In Subjects With Alzheimer's Disease With Existing Neuropsychiatric Symptoms On Donepezil
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: PF-05212377 (SAM-760); Placebo
Intervention description: 30 mg QD of PF-05212377 (SAM-760); Placebo QD
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 186.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Randomized; Double Blind; Safety and Efficacy

Summary:

      This study will evaluate safety and efficacy of PF-05212377 in subjects with mild-to-moderate
      Alzheimer's Disease with existing neuropsychiatric symptoms on a stable dose of Donepezil.
      The 4-week run-in will minimize placebo effect. The 12-week treatment period is considered
      the minimum length necessary to reliably evaluate the effect PF-05212377 on cognition and and
      neuropsychiatric symptoms in this population. The 2-week washout will allow to monitor
      re-emergence of neuropsychiatric and cognitive symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of probable AD with supportive brain imaging documentation

          -  Have existing neuropsychiatric symptoms as defined by a score equal or greater than 10
             on the NPI at screening, arising from item scores equal or greater than 2 (frequency X
             severity) on at least 2 domains.

          -  Has been on donepezil (stable dose of 5 mg or 10 mg) for at least four months, with no
             intent to change such for the duration of the study.

        Exclusion Criteria:

          -  Demonstrate extreme agitation, physical aggression or violence to themselves, their
             caregiver, or others, and/or an inability to complete the ADAS-cog assessment at
             Screening.

          -  Have major structural brain disease other than Alzheimer's Disease

          -  Other severe acute or chronical medical or psychiatric condition or laboratory
             abnormality
A Study to Evaluate the Efficacy, Safety, and Tolerability of Guselkumab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa (HS)
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: Guselkumab dose 1; Guselkumab dose 2; Guselkumab dose 3; Placebo
Intervention description: Participants will receive guselkumab dose 1 IV.; Participants will receive guselkumab dose 2 SC in Group 1, 2 and Group 3.; Participants will receive guselkumab dose 3 SC in Group 3.; Participants will receive matched placebo SC and IV in group 1, 2 and 3 with an additional placebo SC dose in Group 3.
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 184.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab
      in adult participants with moderate to severe hidradenitis suppurativa (HS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have moderate to severe Hidradenitis Suppurativa (HS) for at least 1 year (365 days)
             prior to the baseline visit as determined by the investigator through participant
             interview and/or review of the medical history

          -  Have HS lesions present in at least 2 distinct anatomic areas (examples include but
             are not limited to left and right axilla; or left axilla and left inguinocrural fold)

          -  Had an inadequate response to an adequate course of appropriate oral antibiotics for
             treatment of HS (or demonstrated intolerance to, or had a contraindication to oral
             antibiotics for treatment of their HS) in the investigator's opinion

          -  Have a total abscess and inflammatory nodule (AN) count of greater than or equal to
             (>=) 3 at the screening and baseline visit

          -  Must agree to daily use (throughout the entirety of the study) of one of the following
             over-the-counter treatments to the body areas affected with HS lesions: either soap
             and water, or a topical antiseptic wash containing chlorhexidine gluconate, triclosan,
             or benzoyl peroxide, or a dilute bleach bath

        Exclusion Criteria:

          -  Any other active skin disease or condition (example, bacterial, fungal or viral
             infection) that could have interfered with assessment of HS

          -  Has a draining fistula count of greater than (>) 20 at the baseline visit

          -  Receipt of prescription topical therapies for the treatment of HS within 14 days prior
             to the baseline visit

          -  Receipt of systemic non-biologic therapies for the treatment of HS less than (<) 4
             Weeks prior to the baseline visit

          -  Receipt of any oral antibiotic treatment for HS or inflammatory disorders within 4
             Weeks prior to the baseline visit
Effects of Angeliq and Prempro on Blood Pressure and Sodium Sensitivity in Postmenopausal Women With Prehypertension
Condition: Postmenopause; Hypertension; Pre-Hypertension
MeSH terms: Hypertension; Prehypertension
Intervention: Drospirenone/17ß-estradiol (Angeliq, BAY86-4891); Drospirenone/17ß-estradiol (Angeliq, BAY86-4891); SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM)
Intervention description: SH K 00641 A -Active study medication encapsulated tablet; SH K 00641 B - Active study medication encapsulated tablet; Active control encapsulated tablet
Intervention MeSH terms: Medroxyprogesterone Acetate; Drospirenone; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Medroxyprogesterone; Ethinyl Estradiol; Drospirenone and ethinyl estradiol combination; Estradiol; Polyestradiol phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 92.0
Sex: Female
Minimum age: 45 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Pre-Hypertension in Postmenopausal Women

Summary:

      The main purpose of this study is to compare the effects of treatment of two different
      formulations of Angeliq® and Prempro on blood pressure in post-menopausal women with
      prehypertension.
    

Eligibility criteria:

        Inclusion Criteria:

        - Postmenopausal women 45 - 65 years old with prehypertension

        Exclusion Criteria:

        - Hormone therapy (estrogen/progestin)
12 Weeks Treatment With 3 Different Doses of BI 10773 in Type 2 Diabetic Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: BI 10773; placebo; metformin
Intervention MeSH terms: Metformin; Empagliflozin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Enrollment: 408.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The objective is to investigate the efficacy, safety and pharmacokinetics of three different
      doses of BI 10773 compared to placebo given for 12 weeks in patients with type 2 diabetes
      mellitus with insufficient glycemic control. In addition an open-label metformin arm will be
      assessed
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients with a diagnosis of type 2 diabetes mellitus

          -  either treatment-naïve or on a maximum of 1 oral antidiabetic therapy on a stable dose
             for the10 weeks prior to screening

          -  HbA1c ≥6.5 to ≤9.0% and for treatment-naïve patients:HbA1c >7.0 to ≤10.0%

          -  HbA1c >7.0 to ≤10.0% at Visit 2 (start of run-in) for all patients

          -  Age between 18 and 80 years

          -  BMI less than 40 kg/m2

          -  Signed and dated informed consent prior to admission to the study in accordance with
             GCP and local legislation

        Exclusion Criteria:

          1. Myocardial infarction, stroke or TIA within 6 months prior to informed consent

          2. Impaired hepatic function

          3. Renal insufficiency or impaired renal function

          4. Disease of central nervous system, or psychiatric disorders or clinically relevant
             neurologic disorders that may interfere with trial participation

          5. Chronic or clinically relevant acute infections

          6. Current or chronic urogenital tract infection determined by medical history

          7. History of clinically relevant allergy/hypersensitivity

          8. Treatment with glitazones, GLP-1 analogues or insulin within 3 months prior to
             informed consent

          9. Treatment with anti obesity drugs

         10. Current treatment with systemic steroids

         11. Alcohol abuse

         12. Treatment with an investigational drug within 2 months prior to informed consent

         13. known intolerance to metformin

         14. Dehydration

         15. Unstable or acute CHF

         16. Acute or chronic acidosis

         17. Hereditary galactose intolerance

         18. Woman of child bearing potential who are nursing or pregnant or not practicing an
             acceptable method of birth control
Glucose Oxidase as Treatment Against Common Cold
Condition: Common Cold
MeSH terms: Common Cold
Intervention: Glucose oxidase + glucose; Saline+glucose
Intervention description: Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device; Placebo arm
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Duration

Summary:

      Glucose oxidase is a hydrogen peroxide producing enzyme, which also is present in honey.
      Human rhinoviruses are sensitive to the action of hydrogen peroxide, which is documented in
      laboratory studies.

      In the present study we aim to investigate if a nasal spray with glucose oxidase could treat
      a common cold, when the treatment is started even after the onset of the symptoms. The study
      is randomized and placebo controlled.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Symptoms of a common cold within the last 24 hours

        Exclusion Criteria:

          -  Use of a nasal steroid due to allergy
A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of SUN13834 in Adult Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: SUN13834; Placebo
Intervention description: Low dose, orally 3 times a day (tid) for 28 days of SUN13834; Placebo, orally (tid) for 28 days of SUN13834
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 270.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Atopic Dermatitis; SUN13834

Summary:

      The purpose of the study is to explore the efficacy and safety of SUN13834 vs placebo in
      adult participants with atopic dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants between 18 and 65 years of age.

          -  A diagnosis of Atopic Dermatitis (AD), meeting the Guidelines for Diagnosis of Atopic
             Dermatitis criteria

          -  At least 1 inflammatory lesion Eczema Area and Severity Index (EASI) score ≥5 at
             Screening and prior to randomization (as per Amendment 2 and 3). Under the original
             protocol and Amendment 1, no minimum EASI score was required.

        Exclusion Criteria:

          -  Taking systemic immunosuppressive drugs or biologicals (within 3 months), or systemic
             corticosteroids therapy (within 4 weeks)prior to Screening(note: inhaled, intranasal
             or otic corticosteroids are allowed).

          -  Use of phototherapy or tanning beds within 6 weeks of screening

          -  History of reactive airway disease (asthma) requiring hospitalization in an intensive
             care unit in the last 5 years.

          -  Presence of a clinically significant disorder involving the cardiovascular,
             respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or
             neurologic system(s) or psychiatric disease (as determined by the Clinical
             Investigator) that will interfere with the interpretation of data from this patient
             (eg, renal impairment with non-atopic pruritus).