bioihbjkbjnl/mcl2 huggingface dataset:
Dosing Study of Ranibizumab for Diabetic Retinal and Macular Edema
Condition: Diabetic Retinopathy; Macular Edema
MeSH terms: Macular Edema; Diabetic Retinopathy; Edema
Intervention: Ranibizumab; Ranibizumab
Intervention description: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.; Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.
Intervention MeSH terms: Ranibizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Diabetic Macular Edema; Diabetic Retinal Swelling; DIabetic Eye Disease

Summary:

      This study is to see whether treating diabetic retinal swelling with ranibizumab injections
      into the eye monthly is better than treating diabetic retinal swelling with ranibizumab
      injections into the eye less frequently.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to provide written informed consent and comply with study assessments for the
             full duration of the study

          -  Age > 18 years

          -  Patient related considerations

          -  Phakic or pseudophakic patients with a known history of diabetes will be eligible.

          -  Women of reproductive age will be required to take a urine pregnancy test prior to
             administration of the study drug.

          -  Disease related considerations:

          -  Patients will have met standard, accepted diagnostic criteria for diabetes and will be
             currently treated with at least one systemic antihyperglycemic or insulin medication.

          -  Patients will have a BCVA ETDRS Snellen-equivalent less than or equal to 20/40

          -  Central foveal thickness on SD-OCT of >300um

        Exclusion Criteria:

          -  Pregnancy (positive pregnancy test) or lactation Premenopausal women not using
             adequate contraception. The following are considered effective means of contraception:
             surgical sterilization or use of oral contraceptives, barrier contraception with
             either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or
             contraceptive hormone implant or patch.

          -  Any other condition that the investigator believes would pose a significant hazard to
             the subject if the investigational therapy were initiated

          -  Participation in another simultaneous medical investigation or trial

          -  Foveal ischemia on IVFA

          -  Intraocular surgery less than 6 months ago

          -  Epiretinal membrane of clinical significance

          -  Prior vitrectomy

          -  Uncontrolled glaucoma

          -  Macular or peripheral laser within 90 Days from Day 0 injection

          -  Intravitreal steroid injection within 90 days from Day 0 injection

          -  Intravitreal or systemic anti-VEGF within 30 days from Day 0 injection
Hydroxychloroquine and Metabolic Outcomes in Patients Undergoing TPAIT
Condition: Chronic Pancreatitis; Insulin Dependent Diabetes
MeSH terms: Pancreatitis; Pancreatitis, Chronic; Diabetes Mellitus, Type 1
Intervention: Hydroxychloroquine; Placebo
Intervention description: Subjects will receive a pre-transplant 200 mg daily dose of HCQ 30 days before TPAIT and will continue on the drug for 3 months after surgery.; Subjects will receive a pre-transplant placebo 30 days before TPAIT and will continue on the placebo for 3 months after surgery.
Intervention MeSH terms: Hydroxychloroquine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: open label, randomized, two-arm, single-blinded, placebo-controlled, parallel
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: The study will be single-blinded. The PI, biostatistician who will analyze the data, consultants, and technicians running assays will be blinded to the study arm into which the subjects have been randomized. An alphanumeric identifier that refers to the study subject without any indicators of study arm allocation will be used. Only the surgeons and the research coordinator, but not the personnel conducting the metabolic studies, will be un-blinded as to the study arm randomization.
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Pancreatectomy; Autologous Islet Transplantation; Pancreatitis; Diabetes; Hydroxychloroquine

Summary:

      This will be a pilot, 12-month phase II, open label, randomized, two-arm, single-blinded,
      placebo-controlled, parallel clinical trial of individuals undergoing TPAIT (Total
      Pancreatectomy and Autologous Islet Transplantation) for treatment of chronic pancreatitis
      (CP). The two study arms consist of HCQ-treated (Hydroxychloroquine) and placebo-treated
      individuals. The purpose of this study is to investigate the effects of HCQ administration
      compared to placebo on islet cell function post-autologous transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinically confirmed diagnosis of chronic pancreatitis (CP)

          -  Intractable abdominal pain

          -  History of failed operation(s) for CP

          -  Recurrent acute pancreatitis

          -  HbA1c <8.0%

          -  Sustained alcohol remission

          -  Chronic narcotic use

        Exclusion Criteria:

          -  Insulin dependence

          -  Pancreatic carcinoma

          -  Pancreatic mass suspicious for carcinoma

          -  Cirrhosis

          -  Portal hypertension

          -  Continued alcohol abuse

          -  Manufacturer's product label-contraindicated use of HCQ

          -  History of retinopathy

          -  Actual weight at enrollment <40 Kg
Oral Low-Dose Naltrexone for Lichen Planopilaris and Frontal Fibrosing Alopecia
Condition: Lichen Planopilaris; Frontal Fibrosing Alopecia
MeSH terms: Alopecia; Alopecia Areata; Lichen Planus
Intervention: Low-Dose Naltrexone
Intervention description: Based on the promising evidence, we propose using low-dose naltrexone at a daily dose of 3mg to treat lichen planopilaris and frontal fibrosing alopecia. The patients would be continued on their other medications for these conditions. The study would be open-label, so all participants would receive the low-dose naltrexone. Patients would be seen at 0,3,6 and 12 months to monitor their progress.
Intervention MeSH terms: Naltrexone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Oral naltrexone was initially FDA approved to treat opioid use disorder and alcohol
      dependence at doses from 50-100mg/day. At lower doses of 1-5mg/day, naltrexone has been used
      off-label with success in treatment of several dermatologic conditions including the scarring
      hair loss disease lichen planopilaris. A recent case series of four patients with lichen
      planopilaris and a subtype, frontal fibrosing alopecia, treated with oral low-dose naltrexone
      at 3mg daily showed reduction of itch, clinical evidence of inflammation of the scalp, and of
      disease progression. There were no reported adverse events.

      Based on the promising evidence, we propose using low-dose naltrexone at a daily dose of 3mg
      to treat lichen planopilaris and frontal fibrosing alopecia. The patients would be continued
      on their other medications for these conditions. The study would be open-label, so all
      participants would receive the low-dose naltrexone. Patients would be seen at 0,3,6 and 12
      months to monitor their progress.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults age 18 or greater

          -  clinically or histologically confirmed diagnosis of lichen planopilaris or frontal
             fibrosing alopecia

        Exclusion Criteria:

          -  known allergy or hypersensitivity to naltrexone

          -  patients with concurrent use of opioids

          -  active depression, schizophrenia, and bipolar disorder
Phase II Safety and Efficacy Study of 18FDOPA PET-CT in Children With Hyperinsulinemic Hypoglycemia
Condition: Congenital Hyperinsulinism (CHI); Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI)
MeSH terms: Congenital Hyperinsulinism; Nesidioblastosis; Hypoglycemia; Hyperinsulinism
Intervention: 18 F-DOPA
Intervention description: 1 time injection of 0.08 - 0.16 mCi/kg of 18F-DOPA
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 130.0
Sex: All
Healthy volunteers: No
Keywords: Congenital Hyperinsulinism (CHI); hyperinsulinism; Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI); CHI; PHHI; Pancreatectomy; 18F-DOPA; PET/CT scan

Summary:

      Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these
      children may require surgery to remove part or all of their pancreas. In this study,
      researchers will test how well a radioactive drug, 18-labeled L-fluorodeoxyphenylalanine
      (called F-DOPA) can detect a form of hyperinsulinism (focal HI) that may be cured by surgery.
      Eligible participants in this study will have positron emission tomography/computerized
      tomography (PET/CT) scans with F-DOPA prior to surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infants and children with a clinical diagnosis of hyperinsulinism who are suspected to
             have focal disease and are surgical candidates for pancreatectomy

        Exclusion Criteria:

          -  Pregnant or lactating females

          -  Any other major illness or condition that might substantially increase the risk
             associated with the subject's participation in this study.
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Imsidolimab; Placebo
Intervention description: Humanized Monoclonal Antibody; 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: 123.0
Sex: All
Minimum age: 12 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: LI-36 Receptor; Interleukin 36; Imsidolimab

Summary:

      Efficacy and Safety of Imsidolimab in Participants with Acne Vulgaris
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Diagnosis of moderate to severe facial AV

          -  Facial IGA) score of 3 (moderate) or 4 (severe)

          -  At least 20 and no more than 100 inflammatory lesions on the face

          -  No more than 100 non-inflammatory lesions on the face.

          -  No more than 5 nodules (≥5 millimeter [mm]) on the face

        Key Exclusion Criteria:

          -  A participant with acne fulminans or conglobate or secondary acne will be excluded.
Safety and Efficacy of Etrasimod (APD334) in Patients With Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Etrasimod; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 156.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether etrasimod is a safe and effective treatment
      for ulcerative colitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderately to severely active ulcerative colitis defined as a 3-component Mayo Clinic
             score

          -  Evidence of colonic ulcerative colitis activity on endoscopy

        Exclusion Criteria:

          -  Within 30 days prior to randomization, receipt of any of the following for the
             treatment of underlying disease: Non-biologic therapies (eg, cyclosporine, tacrolimus,
             tofacitinib, thalidomide), a non-biologic investigational therapy or an approved
             non-biologic therapy in an investigational protocol

          -  Within 60 days prior to randomization, receipt of any of the following: Infliximab,
             adalimumab, golimumab, certolizumab, vedolizumab, any other investigational or
             approved biologic agent

          -  Any prior exposure to natalizumab, efalizumab, or rituximab
DS-8201a in Human Epidermal Growth Factor Receptor2 (HER2)-Expressing Colorectal Cancer (DESTINY-CRC01)
Condition: Colorectal Neoplasm
MeSH terms: Colorectal Neoplasms
Intervention: DS-8201a
Intervention description: DS-8201a is comprised of an antibody component conjoined to a drug component in a lyophilized powder, which is made into solution for intravenous administration
Intervention MeSH terms: Trastuzumab; Trastuzumab deruxtecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Oncology; HER2; Colorectal cancer; Antibody drug conjugate; ADC

Summary:

      The main objective of this study is to test the safety and effectiveness of DS-8201a for
      participants with HER2-expressing advanced colorectal cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has pathologically documented unresectable, recurrent, or metastatic colorectal
             adenocarcinoma (until sponsor's notification to the study sites, subject must be a
             RAS/BRAF wild-type cancer)

          -  Has received at least 2 prior regimens of standard treatment

          -  Has measurable disease assessed by the investigator based on RECIST version 1.1.

          -  Has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1

        Exclusion Criteria:

          -  Has a medical history of myocardial infarction within 6 months, symptomatic congestive
             heart failure

          -  Has a medical history of clinically significant lung disease

          -  Has spinal cord compression or clinically active central nervous system metastases,
             defined as untreated and symptomatic, or requiring therapy
Vitamin D and Breast Cancer: Does Weight Make a Difference?
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Vitamin D
Intervention MeSH terms: Vitamin D; Cholecalciferol
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 41.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Vitamin D; Obesity

Summary:

      This is a research study of the effect of Vitamin D on breast cancer. We hope to learn
      whether Vitamin D can change characteristics of certain genes in a breast cancer tumor that
      affect its growth. We believe some of these characteristics may be influenced by body weight.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women who have undergone a core needle biopsy demonstrating an operable breast cancer
             whom have not yet had any further therapy.

          -  No prior therapy for breast cancer.

          -  Age 18 years or older.

          -  Any menopausal status

          -  Planned surgical resection of breast cancer or repeat core biopsy tissue sampling
             prior to initiation of neoadjuvant systemic chemotherapy.

          -  Availability of tissue blocks from initial core needle biopsy.

          -  Signed informed consent.

          -  Willing to discontinue use of all supplements containing Vitamin D for the duration of
             the study, and take only the Vitamin D provided by the study.

        Exclusion Criteria:

          -  Presence of any Metastatic lesion.

          -  History of parathyroid disease, hypercalcemia, or kidney stones.

          -  History of Selective estrogen receptor modulator (SERM) or aromatase inhibitor
             therapy.

          -  Receiving metformin.

          -  History of renal failure requiring dialysis or kidney transplantation.

          -  Women who are known to be pregnant or who are nursing. (As vitamin D does not have
             toxicity to the fetus, a negative pregnancy test is not a requirement to participate
             in the study.)

          -  Patients planned for surgical therapy of their breast cancer or initiation of systemic
             chemotherapy, that would not allow for at least 7 days of vitamin D intervention

          -  Any condition potentially interfering with subjects ability to comply with taking
             study medication.

          -  Any medical condition that would potentially interfere with vitamin D absorption.

          -  Current participation in another research study that would increase risk to subject,
             in the opinion of the investigators.

          -  Patients currently taking more than 2000 IU of Vitamin D.
COVID-19 PrEP HCW HCQ Study
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Hydroxychloroquine (HCQ)
Intervention description: Loading dose: 600 mg, oral, 1 day Maintenance dose: 200 mg, oral, daily, for 90 days
Intervention MeSH terms: Hydroxychloroquine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Total number of participant: 350 (Group A and B)
Group A: projected 300 (HCW choose to be provided HCQ)
Group B: projected 50 (HCW choose not to be provided HCQ)
Masking: None (Open Label)
Masking description: Open Label
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Off label study to evaluate the efficacy of HCQ for pre-exposure prophylaxis (PrEP) to
      prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. 350
      participants will be assigned to the group that takes HCQ or the group that opts to not take
      the study medication. Participants will be NYULH HCW at high risk for occupational exposure
      to SARS-CoV-2. Study timepoints will include screening/enrollment, 30 day, 60 day, and 90 day
      visits. Questionnaires, and DBS will be collected in all timepoints.
    

Eligibility criteria:

        Inclusion Criteria for Group A and B

          -  Men or women ages ≥18 years NYULH health care worker who meets one of the following
             criteria

               1. Involved in an aerosol generating procedure (nasopharyngeal specimen collection,
                  tracheal intubation, nebulizer treatment, open airway suctioning, collection of
                  sputum, tracheostomy, bronchoscopy, CPR) on a confirmed COVID-19 patient while
                  wearing PPE

               2. Direct bedside care of confirmed COVID-19 patient while wearing PPE for 3 or more
                  shifts in a 7 day period

               3. Direct care of PUIs in the ED or other inpatient unit while wearing PPE for 3 or
                  more shifts in a 7 day period

          -  Willing and able to provide informed consent

        Exclusion Criteria for Group A only :

          -  Known hypersensitivity to hydroxychloroquine or chloroquine

          -  Known diagnosis of COVID-19

          -  Concomitant use of

               1. amiodarone

               2. digoxin

               3. flecainide

               4. procainamide

               5. propafenone

          -  History of Torsades de pontes

          -  History of retinal disease

          -  Known chronic kidney disease ≥ stage 4

          -  Congenital prolonged QTc interval syndrome (Jervell and Lange-Nielsen syndrome,
             Romano-Ward syndrome)
Intranasal Administration of Neuropeptide Y in Healthy Male Volunteers
Condition: Mood Disorder; Anxiety Disorders
MeSH terms: Anxiety Disorders; Mood Disorders
Intervention: Low dose NPY; High dose NPY; Placebo
Intervention description: 50nmol, administered intranasally; 100nmol administered intranasally; placebo comparator (0nmol)) administered intranasally
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 10.0
Sex: Male
Minimum age: 25 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Mood Disorder; Anxiety Disorders

Summary:

      There is growing evidence that neuropeptides act as neuronal messengers in the brain and have
      diverse functions that may include the regulation of mood and behavior. For example,
      neuropeptide Y (NPY) is thought to play a role in the adaptive stress response. The
      therapeutic application of neuropeptides for psychiatric disorders has been limited by
      difficult and unreliable penetration of the blood-brain barrier (BBB). However, recent data
      suggest that intranasal administration may provide a means of effectively delivering some of
      these neuropeptides to the brain. Thus far it is unclear if this is the case for NPY. The
      aims of this project are:

        1. To evaluate, in 15 healthy male volunteers aged 25-45, the effect of intranasal NPY
           administration (0, 50 and 100 nmol) on its levels in cerebrospinal fluid (CSF), measured
           by means of lumbar puncture using an intraspinal catheter between L4 and L5, and in
           plasma, measured using an intravenous catheter in the forearm. One of the three
           treatments will be administered to each participant in a double-blind fashion. The 0
           nmol condition will serve as the placebo control.

        2. To test the effect of intranasal NPY administration on mood and anxiety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men aged 25-45.

          -  No history of Axis I disorder as defined in the DSM-IV other than past nicotine abuse
             or dependence or adjustment disorder.

        Exclusion Criteria:

          -  Nicotine or caffeine abuse or dependence within the preceding 3 months.

          -  History or complaint of nasal disorders or allergies.

          -  Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory,
             cardiovascular, endocrinologic, neurologic, immunologic, or hematologic.

          -  Significant obesity (BMI > 30), scoliosis, spinal stenosis or a history of lumbosacral
             laminectomy.

          -  Clinically significant abnormal findings of laboratory parameters, physical
             examination, or ECG.

          -  Current use of any medications that have effects on CNS function.

          -  Prior sinonasal surgery, or significant nasal polyps as determined by nasal endoscopy.