bioihbjkbjnl/mcl2 huggingface dataset:
Phase 2b Study to Evaluate the Efficacy and Safety of ISB 830 in Adults With Moderate to Severe Atopic Dermatitis
Condition: Moderate to Severe Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: ISB 830 - Part 1 Group 1; ISB 830 - Part 1 Group 2; ISB 830 - Part 1 Group 3; Placebo - Part 1 Group 4; ISB 830 - Part 2 Group 5; Placebo - Part 2 Group 6
Intervention description: Subcutaneous injection (SC) every 2 weeks; Subcutaneous injection (SC) every 2 weeks; Subcutaneous injection (SC) every 2 weeks; Subcutaneous injection (SC) every 2 weeks; Subcutaneous injection (SC) every 2 weeks; Subcutaneous injection (SC) every 2 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blind
Enrollment: 462.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ISB 830, OX40, atopic dermatitis

Summary:

      Phase 2b, randomized, double-blinded, placebo-controlled dose range finding study to evaluate
      the efficacy, safety and tolerability of ISB 830 in adults with moderate to severe atopic
      dermatitis. The study will be conducted in 2 Parts, with dosing Groups 1-4 comprising Part 1,
      and dosing Groups 5-6 comprising Part 2. All subjects will receive open-label ISB 830 after a
      16 week blinded treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects aged ≥18 years with physician diagnosis of atopic dermatitis
             for >1 year as defined by American Academy of Dermatology Consensus Criteria.

          -  Atopic dermatitis involvement of ≥10% of body surface area at screening and baseline.

          -  EASI score of ≥12 at screening or ≥16 at baseline.

          -  IGA score of ≥3 at screening and baseline (on the 0 to 4 IGA scale, in which 3 is
             moderate and 4 is severe)

          -  Baseline Pruritus Numerical Rating Scale (NRS) score for maximum itch intensity ≥3
             over the previous 24 hours.

        Exclusion Criteria:

          -  Pregnant or lactating women.

          -  Prior treatment with ISB 830

          -  Treatment with biologics

          -  Systemic corticosteroids, immunosuppressive/immunomodulatory drugs or phototherapy
             within 4 weeks of baseline

          -  Active chronic or acute infection requiring systemic treatment
Treatment of Fragile-X Associated Tremor/Ataxia Syndrome (FXTAS) With Allopregnanolone
Condition: Fragile X-associated Tremor/Ataxia Syndrome
MeSH terms: Ataxia; Cerebellar Ataxia; Tremor; Syndrome
Intervention: Allopregnanolone
Intervention description: Allopregnanolone is an endogenous inhibitory pregnane neurosteroid. It is synthesized from progesterone, and is a potent positive allosteric modulator of the action of γ-aminobutyric acid at GABAA receptor. Subjects will receive up to 12 infusions in the study. Subjects will all begin with 2.0 mg dosage. If tolerated, the next infusion will be 4.0 mg, and if that is tolerated, the next infusion will be 6.0 mg. Subject infusions will remain stable at the highest dosage tolerated for the remainder of the study. Each infusion will consist of 2.0 mg, 4.0 mg, or 6.0 mg aliquots of the 0.5 mg/ml allopregnanolone in 6% sulfobutylether-β-cyclodextrin with 0.9% sodium chloride injection solution.
Intervention MeSH terms: Pregnanolone; Brexanolone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to examine the safety and efficacy of Allopregnanolone as a
      possible treatment for symptoms of Fragile X-associated Tremor/Ataxia Syndrome (FXTAS).
    

Eligibility criteria:

        Inclusion Criteria

          -  Fragile X premutation carrier status (55 to 200 CGG repeats in FMR1),

          -  Diagnosis of FXTAS including an intention tremor and/or ataxia and/or deficits on the
             BDS-2 demonstrating executive function deficits.

        Exclusion Criteria

          -  other genetic problems in addition to the premutation

          -  a history of significant brain trauma

          -  significant substance abuse

          -  inability to follow the protocol

          -  liver or kidney disease

          -  heart failure

          -  active cancer

          -  other serious systemic disease

          -  current use of phenytoin
Randomized Comparison of Combination Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone for the Treatment of Confirmed COVID-19
Condition: SARS-CoV-2; COVID-19
MeSH terms: COVID-19
Intervention: Hydroxychloroquine Sulfate + Azithromycin; Hydroxychloroquine Sulfate
Intervention description: Given PO; Given PO
Intervention MeSH terms: Azithromycin; Hydroxychloroquine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a three-arm randomized trial comparing the efficacy of single agent
      hydroxychloroquine to the combination of hydroxychloroquine and azithromycin, and to a
      delayed hydroxychloroquine regimen, which will serve as a contemporaneous Day 1-6 supportive
      care control, in eliminating detectable SARS-CoV-2 on day 6 following the initiation of
      treatment in order to determine which regimen is more effective.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with proven SARS-CoV-2 infection by an accepted assay with symptoms
             consistent with COVID-19

          -  Ability to measure and quantify viral load by quantitative PCR

          -  Age 18 to 89

          -  Ability to swallow oral medications

          -  Patients must read, understand and sign IRB approved informed consent

        Exclusion Criteria:

          -  Pregnancy or women who are breast feeding

          -  Two consecutive negative assays for SARS-CoV-2 infection

          -  Patients that lack decision-making capacity will not be approached to participate in
             this study

          -  Inability to tolerate oral medications

          -  Allergy or prior adverse reaction to either azithromycin or hydroxychloroquine sulfate

          -  QTc interval > 470 mSEC

          -  History of ongoing ventricular cardiac dysrhythmias of grade 2 as described by NCI
             CTCAE 5.0 criteria

          -  History of serious ventricular arrhythmia (VT or VF > 3 beats in a row)
Open-label Extension Study to Assess Safety and Tolerability of LYC-30937-EC in Subjects With Active Ulcerative Colitis
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: LYC-30937-EC
Intervention description: LYC-30937-EC 25 mg by mouth once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to allow subjects completing study LYC-30937-2001 the
      opportunity to receive LYC-30937-EC 25 mg.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed the 8-week double-blind treatment period of study LYC-30937-2001

          -  Male and females of childbearing potential must agree to use adequate birth control
             during the study and for 30 days after discontinuing study drug

          -  Non-pregnant, non-lactating females who are not planning to become pregnant while
             enrolled in this study

          -  Investigator considers it safe and potentially beneficial to participate

          -  Ability to provide written informed consent and to be compliant with study schedule

        Exclusion Criteria:

          -  Subjects who completed study LYC-30937-2001, but who experienced a serious adverse
             event that was considered related to investigational product, has an unstable medical
             condition, or for any other reason in the opinion of the investigator should not
             participate in this study
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
A Multi-Center Controlled Screening Trial of Safety and Efficacy of Lithium Carbonate in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Intervention: lithium carbonate
Intervention description: The dosage of lithium carbonate will be adjusted for each individual. The maximum dose is 450mg/day.
Intervention MeSH terms: Lithium Carbonate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 109.0
Sex: All
Minimum age: 21 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: ALS; Amyotrophic Lateral Sclerosis; Lou Gehrig's Disease; Lithium; Lithium Carbonate

Summary:

      This is a Phase II screening study of lithium carbonate in ALS. The purpose of this study is
      to find out if lithium carbonate is safe to be used in people with ALS and if it can slow the
      progression of the disease. Since there is no placebo in this study, all patients will be
      taking lithium carbonate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of laboratory-supported probable, probable, or definite ALS

          -  Vital capacity of at least 75% of predicted

          -  Onset of weakness within 3 years prior to enrollment

          -  If patients are on riluzole, they must be on a stable dose for at least 30 days prior
             to baseline visit

          -  Women of childbearing potential must be surgically sterile or using an effective
             method of birth control and have a negative pregnancy test

          -  Willing and able to give informed consent

        Exclusion Criteria:

          -  Diagnosis of other neurodegenerative disease

          -  Need tracheotomy ventilation or non-invasive ventilation 23 or more hours/day

          -  Clinically significant history of any unstable medical condition in past 30 days

          -  History of renal

          -  History of liver disease

          -  Current pregnancy or lactation

          -  Use of lithium within thirty days of enrollment

          -  Significantly limited mental capacity

          -  History of recent drug or alcohol abuse

          -  Use of any investigational drug within 30 days prior to enrollment
Long-Term Vesicular Monoamine Transporter II Imaging and Clinical Assessment of Parkinson's Disease Progression
Condition: Parkinson Disease
MeSH terms: Parkinson Disease; Disease Progression
Intervention: 18F-DTBZ AV-133
Intervention description: A total 40 PD subjects will be included in this study. PD subjects between 20 and 80 years of age may be eligible for this study. Candidates are screened with a medical history and physical examination, and blood test.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: 18F-DTBZ AV-133 imaging

Summary:

      A total 40 PD subjects will be included in this study. PD subjects between 20 and 80 years of
      age may be eligible for this study. Candidates are screened with a medical history and
      physical examination, and blood test.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female age 20 years to 80 years.

          2. Patients should be fulfilled Criteria of diagnosis of Parkinson disease of "possible"
             or "probable" PD1.

          3. Patients who provide a written informed consent prior to study entry. If the patient
             is incapable of informed consent, the caregiver may consent on behalf of the patient
             (the patient must still confirm assent)

        Exclusion criteria:

          1. Significant recent (within 6 months) history of neurological (including stroke and
             brain trauma) or psychiatric disorder.

          2. Alcohol or substance abuse.

          3. History or presence of QTc prolongation. (>500msec)

          4. History of intracranial operation, including thalamotomy, pallidotomy, and/or deep
             brain stimulation.

          5. Unable to stay still in the MRI or PET scanner for 30 minutes.

          6. Pregnancy and breast feeding.

          7. Hepatic dysfunction with liver function test (alanine aminotransferase [ALT] and
             aspartate aminotransferase [AST]) of > 3x the upper limit of normal
To Investigate the Efficacy and Safety of OPC-6535 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: tetomilast (OPC-6535); tetomilast (OPC-6535); tetomilast (OPC-6535); placebo
Intervention description: oral administration of 12.5mg OPC-6535, once daily for 24months; oral administration of 25mg OPC-6535, once daily for 24months; oral administration of 50 mg OPC-6535, once daily for 24months; oral administration of placebo, once daily for 24months
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 771.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: chronic obstructive pulmonary disease; COPD; emphysema

Summary:

      To investigate the efficacy and safety of OPC-6535 in COPD patients, using the measurement of
      trough FEV1 over time as the primary endpoint.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 40 to 75 years, inclusive, at the time informed consent is obtained

          -  Ability to provide own written informed consent

          -  Agree to use an appropriate method of contraception until 3 months after the last dose
             of the investigational medicinal product (IMP)

          -  A rating of 1 or higher on the Goddard scale in assessment of emphysema severity by
             chest CT scan at screening

          -  Ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) of
             less than 70% at screening

          -  Cigarette smoking history of at least 20 pack years at screening

        Exclusion Criteria:

          -  Subjects with obstructive disorders due to bronchial asthma

          -  Subjects receiving long-term oxygen therapy

          -  Subjects with active tuberculosis or obvious bronchiectasis

          -  Complication of malignant tumor

          -  Uncontrolled cardiovascular, endocrine, blood, or nervous system disorders

          -  Uncontrolled condition with COPD exacerbation of level 2 or 3 within 8 weeks prior to
             the start of washout period (within 12 weeks prior to start of treatment period)
Assessing Symptomatic Clinical Episodes in Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: AXS-05; Bupropion
Intervention description: AXS-05 taken twice daily for 6 weeks.; Bupropion taken twice daily for 6 weeks.
Intervention MeSH terms: Bupropion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: AXS-05; Major Depressive Disorder; MDD; Axsome; Depression; Dextromethorphan; Bupropion; Sigma-1; NDMA; ASCEND

Summary:

      Randomized, Double-Blind, Active-Controlled Study of AXS-05 for MDD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Currently meets DSM-5 criteria for MDD

          -  Body mass index (BMI) between 18 and 40 kg/m^2, inclusive

          -  Agree to use adequate method of contraception for the duration of the study

          -  Additional criteria may apply

        Exclusion Criteria:

          -  Suicide risk

          -  History of treatment resistance in current depressive episode

          -  History of electroconvulsive therapy, vagus nerve stimulation, transcranial magnetic
             stimulation or any experimental central nervous system treatment during the current
             episode or in the past 6 months

          -  Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study

          -  Additional criteria may apply
Effect of Artificial Tears on Radioiodine Levels in the Nasolacrimal Duct System
Condition: Thyroid Carcinoma; Radioactive Iodine Level
MeSH terms: Carcinoma; Thyroid Neoplasms
Intervention: Artificial Tears
Intervention description: Self-Administered - utilizing eye drop preservative free vials
Intervention MeSH terms: Lubricant Eye Drops
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to explore whether administration of preservative free
      artificial tears will decrease the level of detectable radioiodine in the tears and
      nasolacrimal duct system of patients undergoing radioiodine therapy for thyroid carcinoma and
      thus decrease the risk of developing radioactive iodine associated nasolacrimal duct
      obstruction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Radio-iodine therapy for thyroid cancer

          -  Radioiodine therapy ≥100mCi

          -  Patient wears soft contacts on both eyes

        Exclusion Criteria:

          -  Use of eye drops, other than artificial tears

          -  History of periocular trauma with tear duct involvement/lacrimal gland trauma

          -  History of lacrimal drainage disease: canaliculitis, dacryocystitis

          -  Prior radiotherapy

          -  Current or prior use of chemotherapy drugs (i.e. 5-fluorouracil, docetaxel)

          -  Medical conditions that predispose to NLD stenosis

               -  Sarcoid

               -  Granulomatosis with polyangiitis

               -  Chronic lymphocytic leukemia
Radioactive Iodide Therapy for Pediatric Graves' Disease
Condition: Graves' Disease
MeSH terms: Graves Disease
Intervention: RAI treatment; ATD Group
Intervention description: Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with 131I. In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs).; Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with antithyroid drugs (ATDs). In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Hyperthyroidism; Antithyroid drugs; Cancer; Dosimetry; Children

Summary:

      The investigators hypothesize that 131I is an effective therapy for children with Graves'
      Disease (GD) and will not be associated with long-term cancer risks when used in older
      children, but may be associated with excessive levels of whole body radiation in young
      children. To address issues of 131I safety and cancer risk in the pediatric population, the
      investigators propose to: (1) Perform dosimetry to assess whole body radiation exposure
      following 131I therapy in children treated for GD (2) the investigators will assess
      chromosome translocation as related to age and dose of 131I.

      It is anticipated that these studies will provide new insights into RIA use in children and
      provide important information about radiation exposure associated 131I use in children. As
      such, these studies are expected to result in new recommendations for 131I use in the
      treatment of pediatric GD.

      Funding Source - FDA OOPD
    

Eligibility criteria:

        Inclusion Criteria:

          1. A diagnosis of GD based on initial laboratory studies showing a suppressed TSH (i.e.
             <0.01); high total T3, high total T4 and/or free T4 level; an elevated thyroid
             stimulating immunoglobulin (TSI) titer; increased and diffuse uptake of 123I, 131I, or
             99Tc in the thyroid gland.

          2. Age <18 years at the time of GD disease diagnosis.

          3. Non-smoking parents.

        Exclusion Criteria:

          1. > 18 years.

          2. Smoking parents.