bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Intravitreal VEGF-Trap Eye on Polypoidal Choroidal Vasculopathy
Condition: Exudative Age-related Macular Degeneration; Polypoidal Choroidal Vasculopathy
MeSH terms: Macular Degeneration; Polypoidal Choroidal Vasculopathy; Vascular Diseases
Intervention: aflibercept
Intervention description: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe.
Intervention MeSH terms: Aflibercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Healthy volunteers: No

Summary:

      Effects of VEGF Trap-Eye (aflibercept) in treatment-naive polypoidal choroidal vasculopathy
      (PCV) will be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Submacular PCV diagnosed using ICG angiography with no previous treatment (branching
             vascular network with or without polypoidal dilation in ICG angiography)

          -  Presence of signs of recent activity of PCV

               1. Visual acuity between 20/40 and 20/320

               2. Active leakage in fluorescein angiography

               3. Presence of any fluid in OCT(optical coherence tomography)-intraretinal,
                  subretinal, sub-retinal pigment epithelial

        Exclusion Criteria:

          1. Extramacular PCV

          2. Subretinal hemorrhage or other retinal lesions blocking angiographic characteristics
             in more than 50% area of PCV lesion.

          3. Previous treatment of intravitreal injections (anti-VEGF, steroid or other agents)

          4. Previous treatment of photodynamic therapy

          5. Previous ocular surgery except cataract surgery before 3 or more months

          6. Presence of exudative AMD in the other eyes requiring anti-VEGF treatment
             (Intravitreal bevacizumab was reported to affect the other eye.)

          7. Presence of other ocular diseases which may affect visual acuity (glaucoma, cataract
             with opacity involving visual axis, etc)

          8. Presence of uncontrolled systemic disease (diabetes mellitus, hypertension, ischemic
             heart disease, cerebral infarction, etc)

          9. Patients who cannot understand or conform to the study protocol.

         10. Patients who refuse to agree to the informed consent.

         11. Patients with contraindication to aflibercept

               -  Ocular or periocular infection

               -  Active severe intraocular inflammation

               -  Known hypersensitivity to aflibercept or to any of the excipients
Idiopathic Focal Segmental Glomerulosclerosis (FSGS) and Treatment With ACTH
Condition: Kidney Diseases
MeSH terms: Kidney Diseases; Glomerulosclerosis, Focal Segmental
Intervention: H.P. Acthar Gel
Intervention description: Patients were treated with 40 units subcutaneously (SC) weekly for 2 weeks, then dose increased to 80 units SC weekly for 2 weeks followed by 80 units SC twice weekly to complete 16 weeks of therapy.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 16 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      FSGS is an immunologic disorder wherein circulating immune proteins cause damage to the
      kidneys and progressive injury and scarring. Corticosteroid therapy is occasionally, but not
      nearly universally, successful in reducing proteinuria, and when patients respond, they have
      a favorable prognosis. The investigators believe that ACTH therapy (H.P. Acthar Gel) can
      provide a more rapid, well tolerated reduction in glomerular injury.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1. Biopsy proven FSGS

          -  2. Ability to consent and complete study evaluations

          -  3. Greater than 2g/day of proteinuria

          -  4. No contraindications to treatment with corticosteroids or ACTH

          -  5. Women of childbearing potential will agree to use effective forms of birth control
             throughout this study

        Exclusion Criteria:

          -  1. Known secondary cause of FSGS

          -  2. Receiving active immune therapy (within 90 days)

          -  3. Pregnancy

          -  4. Creatinine >2.5 mg/dl

          -  5. Uncontrolled HTN (>180/100mm Hg)

          -  6. Diabetes

          -  7. Acute or chronic infection

          -  8. Severe comorbidity (active coronary, cerebrovascular disease, cancer, psychiatric
             disease)

          -  9. Age < 16, >65 years

          -  10. Evidence of untreated tuberculosis (+PPD or Ellispot Gold testing)

          -  11. A known contraindication to ACTH. Corticotropin is considered contraindicated in
             patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes
             simplex, recent surgery, history of or the presence of a peptic ulcer, congestive
             heart failure, uncontrolled hypertension, or sensitivity to proteins of porcine
             origin.
Combination Metformin and Oral Contraception for Polycystic Ovary Syndrome (PCOS)
Condition: Polycystic Ovary Syndrome; PCOS; Insulin Sensitivity
MeSH terms: Polycystic Ovary Syndrome; Insulin Resistance; Syndrome
Intervention: placebo; metformin
Intervention description: placebo birth control pill daily; 2000 mg per day for 3 months daily birth control pill
Intervention MeSH terms: Metformin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 28.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this research study is to determine if adding Metformin, a drug that reduces
      insulin resistance, to birth control pills will reduce the risk of developing type 2
      diabetes, high blood pressure. high lipid levels and heart disease in women with PCOS
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 18-45, , 8 menstrual cycles annually, elevated serum free testosterone, normal
             thyroid function test and serum prolactin, exclusion of late onset adrenal hyperplasia

        Exclusion Criteria:

          -  Diabetes mellitus, pulmonary, cardiac, renal, hepatic, cholestatic, neurologic,
             psychiatric, infectious, malignant diseases,history of breast cancer, history of Deep
             Vein Thrombosis, pregnancy and lactation.
Same-Day Mifepristone-Misoprostol Compared to Misoprostol Only for Surgical Abortion Cervical Preparation
Condition: Induced Abortion
Intervention: Mifepristone; Misoprostol; Placebo
Intervention description: Progesterone antagonist; Prostaglandin E1; Tasteless, odorless, sugar based pill
Intervention MeSH terms: Misoprostol; Mifepristone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 100.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A randomized double---blinded comparison of same---day mifepristone and misoprostol with
      misoprostol only for cervical preparation in second---trimester surgical abortion in 100
      women at 14 0/7---19 6/7 weeks gestation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy women

          -  eligible for non---urgent D&E

          -  14 0/7 weeks to 19 6/7 weeks gestation, confirmed by sonogram

        Exclusion Criteria:

          -  emergent need for D&E

          -  fetal demise

          -  intolerance

          -  allergy or contraindication to mifepristone or misoprostol
Duloxetine for Chronic Depression: a Double-blind Study
Condition: Dysthymic Disorder; Depressive Disorder NOS
MeSH terms: Depression; Depressive Disorder; Dysthymic Disorder
Intervention: Duloxetine (Cymbalta)
Intervention description: duloxetine medication up to dose of 120 mg/day
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 65.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: dysthymia; dysthymic disorder; chronic depression; chronic low-grade depression; atypical depression; minor depression; depression NOS; depression; depressive disorder; mood disorder; unipolar depression; low-grade depression

Summary:

      The investigators are studying a new antidepressant medicine, duloxetine, for the treatment
      of people with chronic depression. Duloxetine (trade name Cymbalta) was recently approved by
      the FDA for the treatment of major depression. The investigators are testing whether this
      medicine is also effective for adults with chronic depression (dysthymic disorder or
      dysthymia).

      Chronic depression, lasting two or more years, often causes significant suffering and
      impairment. The investigators study involves a 6 to 10 week double-blind Initial Phase during
      which half of the participants will take the new medication and half will take a placebo (an
      inactive look-alike pill). After the Initial Phase, a 12-week Continuation Phase will begin,
      during which all subjects can be treated with an FDA-approved antidepressant medication.

      Eligible subjects may also receive MRI scans, to help the investigators understand how
      antidepressants work in treating depression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 20 to 75 years (ages 20 to 60 for MRI sub-study)

          -  diagnosis of dysthymic disorder (chronic depression) or depression NOS

          -  minimum of 2 years duration of current episode of depression

        Exclusion Criteria:

          -  current major depression

          -  diagnoses including delirium, dementia, bipolar disorder, schizophrenia

          -  substance abuse or dependence in the past 6 months

          -  pregnant or nursing women

          -  serious risk of suicide
Efficacy Study of Sitagliptin to Prevent New-onset Diabetes After Kidney Transplant
Condition: Posttransplant Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Intervention: Sitagliptin; Placebo
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: diabetes; transplant; kidney

Summary:

      The purpose of this study is to determine whether sitagliptin is effective in preventing the
      development of new-onset diabetes after kidney transplant (NODAT). Up to one-third of
      previously non-diabetic patients develop NODAT after a kidney transplant. Corticosteroids and
      calcineurin inhibitors are two commonly utilized anti-rejection medications that contribute
      to diabetes development through multiple mechanisms; including decreased insulin production
      by the pancreas. Sitagliptin is an oral medication that results in increased insulin
      secretion. We hypothesize that administration of sitagliptin to transplant recipients
      identified to be at risk for diabetes development will reduce the incidence and severity of
      NODAT.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult (≥18 yo) recipient of living-donor or deceased donor kidney transplant

          2. Blood sugar ≥ 200 mg/dL in first 72 hours after transplant

          3. No history of diabetes or prior treatment with insulin or oral hypoglycemic agents

        Exclusion Criteria:

          1. A1c of ≥6.5% measured immediately pre-transplant

          2. Recipient of simultaneous kidney-pancreas, kidney-liver, kidney-heart, or kidney-lung
             transplant

          3. Prior non-renal solid organ transplant
16w Interventional Study on Titration and Dose/Efficacy Assessment of Exelon in Chinese Alzheimer's Disease Patients
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: ENA713
Intervention description: The following strengths of Rivastigmine capsules were provided: Rivastigmine capsule strengths: 1.5mg, 3mg, 4.5mg. The 6mg dose was administered as one 1.5mg capsule and one 4.5mg capsule, and when necessary, the 3mg dose could also be administered as two 1.5mg capsules. Rivastigmine was administered from 3mg/d at baseline. Then dose escalation was made in 3mg/d increments, at a minimun of 4 weeks between dose increases to a maximum dose of 12mg/d or the individual's best tolerated dose.
Intervention MeSH terms: Rivastigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 222.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Alzheimer's disease; ENA713; Chinese patients; INSTINCT

Summary:

      To investigate the efficacy of Exelon capsule at maximal tolerated dose in mild to moderate
      Chinese AD patients via dosage titration from 3mg/d to 12mg/d in a 16 weeks duration
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Have a diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria
             and have a clinical diagnosis of probable AD according to NINCDS/ADRDA criteria

          -  MMSE score of ≥ 10 and ≤ 26

          -  The treatment naïve patient and the one who have stopped the donepezil, galantamine,
             huperzine A, or memantine at least 2 weeks

          -  Be in stable medical condition

          -  Have signed off informed consent form by patients or his/her legal guardian

        Key Exclusion Criteria:

          -  Severe AD

          -  Patients with a history of cerebrovascular disease, Active or uncontrolled epilepsy,
             Active hypothyroidism, asthma, CNS infection, other Neurodegenerative disorders, an
             advanced, severe, progressive, or unstable medical condition

          -  Attending other clinical trials or taking other clinical trial drugs

          -  A score of > 4 on the Modified Hachinski Ischemic Scale (MHIS);

          -  Patients who is using any AChEI or memantine
Safety and Pharmacokinetics of Efinaconazole Topical Solution in Subjects With Mild to Severe Onychomycosis
Condition: Onychomycosis
MeSH terms: Onychomycosis
Intervention: Efinaconazole
Intervention description: Solution
Intervention MeSH terms: Efinaconazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 6 Years
Maximum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Safety and Pharmacokinetics (PK) of a once daily topical application of efinaconazole in the
      treatment of pediatric subjects with mild to severe onychomycosis of the toenails.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female subjects of any race, 6 to 16 years of age (inclusive). PK Subset: Male
             or female subjects of any race, 12 to 16 years of age (inclusive).

          -  Verbal and written informed consent/assent obtained from the subject and/or their
             parent or legal guardian.

          -  Good general health, as assessed by the investigator, based on the subject's medical
             history, physical examination, and safety laboratory tests.

          -  Target great toenail for all subjects, and both great toenails for subjects in the PK
             subset, must have evidence of toenail growth, per subject's report that monthly
             clipping is needed.

          -  Subjects and their parents/legal guardians are willing to comply with study
             instructions and return to the investigational center for all required visits (a visit
             schedule with the length of each visit will be provided to ensure that the subject can
             meet the requirements and have adequate transportation).

        Key Exclusion Criteria:

          -  Females who are pregnant, nursing an infant, or planning a pregnancy during the study
             period.

          -  History of immunosuppression and/or clinical signs indicative of possible
             immunosuppression, as determined by the investigator, or known human immunodeficiency
             virus infection.

          -  History of diabetes that is uncontrolled as determined by the investigator (diabetes
             that is controlled by diet or medication does not exclude a subject).

          -  Presence of any toenail infection other than or in addition to dermatophytes, such as
             Scytalidium as determined by the investigator (candidal onychomycosis infection,
             concurrent with a positive dermatophyte culture, is acceptable).
Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis
Condition: Osteoarthritis; Arthritis, Rheumatoid
MeSH terms: Arthritis; Osteoarthritis; Arthritis, Rheumatoid
Intervention: Celecoxib; Diclofenac + Omeprazole
Intervention description: Participants are assigned to one of two groups in parallel for the duration of the study; Participants are assigned to one of two groups in parallel for the duration of the study
Intervention MeSH terms: Celecoxib; Diclofenac; Omeprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 4484.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: GI events in high risk GI arthritis patients

Summary:

      To determine whether celecoxib is superior to combined therapy with diclofenac and omeprazole
      in the incidence of clinically significant upper and/or lower gastrointestinal (GI) events in
      high GI risk subjects with osteoarthritis and/or rheumatoid arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with a clinical diagnosis of OA or RA and who are expected to require regular
             anti-inflammatory therapy for arthritis symptom management

          -  Subjects must be aged 60 years or older with or without a history of gastroduodenal
             (GD) ulceration; or be of any age 18 years or older and have had documented evidence
             of GD ulceration 90 days or more prior to the screening visit

        Exclusion Criteria:

          -  Active GD ulceration or GD ulceration within 90 days of the screening visit.

          -  Concomitant use of low dose aspirin

          -  Previous MI, stroke or significant vascular disease.
Investigating Veregen ™ 15% Ointment Treatment For Non-facial Verrucae in Pediatric Patients: A Pilot Study
Condition: Verruca, Warts
MeSH terms: Warts
Intervention: Veregen only; Cryotherapy and Veregen
Intervention description: Topical application of Veregen 15% ointment on affected areas twice daily; Cryotherapy followed by topical application of Veregen 15% ointment on affected areas twice daily
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 6 Years
Maximum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to investigate topical treatment with Veregen™ 15% ointment as a
      single therapeutic agent and compare it to combination therapy with Veregen ™ 15% ointment
      and a single destructive treatment by cryotherapy for non-facial verruca vulgaris in the
      pediatric population. This novel treatment modality may be useful in the pediatric
      dermatology community offering a less invasive, painless option for treatment of non-facial
      verruca vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female of any ethnic background

          -  Age between 6 years old and 16 years old

          -  A clinical diagnosis of non-facial verruca vulgaris

          -  Able to adhere to study visit schedule, Veregen ™ treatment requirements, and baseline
             cryotherapy treatment in half of patients

          -  Verruca size greater than 5 mm

        Exclusion Criteria:

          -  Medically unstable patients

          -  Patients with immunosuppression

          -  Families who decline participation

          -  Verruca may not have been treated in preceding 4 weeks prior to enrollment

          -  Verruca may not be located on the face or genitalia

          -  Verruca size less than 5 mm
Brief Intervention to Reduce Fear of Public Speaking
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Intervention: propranolol; Placebo
Intervention description: active treatment; inactive pill
Intervention MeSH terms: Propranolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: propranolol; public speaking anxiety

Summary:

      The study will test the efficacy of propranolol or placebo, administered after retrieval of a
      previously acquired public speaking fear, in reducing fear and avoidance of public speaking.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-60 years of age at the time of consent

          -  Principal Diagnosis of Social Anxiety Disorder, Performance only type

          -  Has clinically significant fear of public speaking

          -  Physically healthy

          -  If female, non-pregnant and not nursing

          -  Off all psychotropic drug for at least 4 weeks

          -  A level of understanding sufficient to provide written informed consent to all
             required study tests and procedures.

        Exclusion Criteria:

          -  History of other serious psychiatric disorder

          -  Current Major Depressive Disorder

          -  Presence of developmental disorder or intellectual disability

          -  SAD patients with SAD not of the performance only type

          -  Women who are pregnant or nursing

          -  Current use of psychiatric medication

          -  Current substance use disorder

          -  Persons planning to start another treatment during the study period.

          -  Any significant medical condition that might increase the risk or participation (e.g.,
             seizure disorder, respiratory disorders [e.g., bronchial asthma], cardiovascular
             disease [e.g., congestive heart failure, heart arrhythmias, sinus bradycardia and
             greater than first degree block ], low blood pressure [ < 90/60], diabetes, liver or
             kidney disorders)

          -  Use of medications that might negatively interact with propranolol (e.g., ACE
             inhibitors; catecholamine depleting drugs, such as reserpine; calcium channel
             blockers; digitalis glycosides; haloperidol; chlorpromazine; aluminum hydroxide gel;
             phenytoin; phenobarbitone; rifampin; antipyrine; lidocaine; cimetidine; theophylline)