bioihbjkbjnl/mcl2 huggingface dataset:
Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma SPECTRUM 6
Condition: Primary Open-angle Glaucoma and Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: DE-117 Ophthalmic Solution QD; DE-117 Ophthalmic Solution BID
Intervention description: DE-117 ophthalmic solution QD and Vehicle (no active DE-117 ingredient) QD add one drop in each eye; DE-117 ophthalmic solution BID twice Daily (20:00 and 8:00) add one drop in each eye
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-masked, parallel-group, multi-center study. Subjects diagnosed
      with POAG or OHT who meet eligibility criteria at Visit 1 (Screening) will wash out their
      current topical IOP lowering medication(s), if any. After completing the required washout
      period, subjects will return for Visit 2 (Baseline, Day 1). Subjects who meet all eligibility
      criteria at Visit 2 (Baseline, Day 1) will be randomized to receive study medication for up
      to 6 weeks.

      Approximately 100 subjects with POAG or OHT will be randomized in a 1:1 ratio to either:

        -  DE-117 ophthalmic solution 0.002% QD (Once Daily)

        -  DE-117 ophthalmic solution 0.002% BID (Twice Daily)

      This study will consist of a screening period of up to 35 days including a washout period of
      up to 28 days (+ 7 days window), and a 6-week double-masked treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

        Provide signed written informed consent

          -  Have a diagnosis of POAG or OHT in both eyes, or one eye with POAG and the other with
             OHT.

          -  Qualifying corrected visual acuity in each eye

          -  Qualifying central corneal thickness in each eye

          -  Qualifying Day 1 IOP measurement at 3 time-points in both eyes

          -  Qualifying Anterior chamber angle

        Exclusion Criteria:

          -  History of ocular surgery specifically intended to lower IOP

          -  Subjects who cannot safely discontinue use of ocular hypotensive medications during
             the wait/washout period

          -  Advanced glaucoma in either eye

          -  Any corneal abnormality or other condition interfering with or preventing reliable
             Goldmann applanation tonometry

          -  Any ocular surgery or ocular laser treatment within 180 days prior to Screening and
             throughout the study in either eye

          -  Females who are pregnant, nursing, or planning a pregnancy
Employment-Based Depot Naltrexone Clinical Trial
Condition: Opiate Dependence
MeSH terms: Opioid-Related Disorders
Intervention: employment-based reinforcement
Intervention description: Participants in the "Work Plus Naltrexone Contingency" condition were required to take scheduled doses of depot naltrexone to work and earn wages.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: opiate dependence; naltrexone; reinforcement; behavior therapy; cocaine dependence; risk reduction behavior

Summary:

      The purpose of this study is to determine whether employment-based naltrexone treatment
      proves effective in promoting depot naltrexone adherence and drug abstinence.
    

Eligibility criteria:

        Individuals were eligible if they:

          -  met the Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition (DSM-IV)
             criteria for opioid dependence,

          -  reported using heroin on at least 21 of the last 30 days while in community,

          -  were unemployed,

          -  were aged 18-65 years,

          -  were medically approved for naltrexone

          -  lived in or near Baltimore, MD.

        Individuals were excluded if they

          -  had current DSM-IV major Axis I disorders,

          -  had current suicidal or homicidal ideation,

          -  expressed interest in methadone treatment,

          -  were required to use opioids for medical purposes,

          -  earned more than $200 in taxable income over the previous 30 days,

          -  had physical limitations that would prevent them from using a keyboard,

          -  were pregnant or breastfeeding,

          -  had serum aminotransferase levels more than three times over normal.
Safety and Efficacy Study of Sebelipase Alfa in Participants With Lysosomal Acid Lipase Deficiency
Condition: Lysosomal Acid Lipase Deficiency
MeSH terms: Wolman Disease
Intervention: Sebelipase Alfa
Intervention description: IV infusion of sebelipase alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 8 Months
Healthy volunteers: No
Keywords: Enzyme Replacement Therapy (ERT); Lysosomal Storage Disease; Late Onset Lysosomal Acid Lipase (LAL) Deficiency; Acid cholesteryl ester hydrolase deficiency, type 2; Acid lipase disease; Cholesterol ester hydrolase deficiency; LAL Deficiency; LIPA Deficiency; Wolman disease; Additional relevant MeSH terms:; Cholesterol Ester Storage Disease; Metabolic Diseases; Lipidoses; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Lysosomal Storage Diseases; Lipid Metabolism Disorders; Infant, Newborn, Diseases

Summary:

      This study evaluated the safety and efficacy of sebelipase alfa in a broad population of
      participants with lysosomal acid lipase deficiency (LAL-D).
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Participant was >8 months of age at the time of dosing.

          2. Confirmation of LAL-D diagnosis as determined by the central laboratory or, for
             participants with prior hematopoietic stem cell transplant or liver transplant,
             historical enzyme activity or molecular genetic testing confirming a diagnosis of
             LAL-D.

          3. Participants >8 months but <4 years of age at Screening had at least 1 of the
             following documented clinical manifestations of LAL-D:

               -  Dyslipidemia

               -  Elevated transaminases

               -  Impaired growth

               -  Suspected malabsorption

               -  Other clinical manifestation of LAL-D

          4. Participants ≥4 years of age at Screening had at least 1 of the following documented
             clinical manifestations of LAL-D:

               -  Evidence of advanced liver disease

               -  Histologically confirmed disease recurrence in participants with past liver or
                  hematopoietic transplant

               -  Persistent dyslipidemia

               -  Suspected malabsorption

               -  Other clinical manifestation of LAL-D

        Key Exclusion Criteria:

          1. Participant had known causes of active liver disease other than LAL-D, which had not
             been adequately treated.

          2. Participant received a hematopoietic stem cell or liver transplant <2 years from the
             time of dosing.

          3. Participant with co-morbidities other than complications due to LAL-D, which were
             irreversible or associated with a high mortality risk within 6 months or would
             interfere with study compliance or data interpretation.
Safety and Efficacy Study for AKB-6548 in Participants With Chronic Kidney Disease and Anemia
Condition: Anemia; Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Intervention: AKB-6548
Intervention description: Different dose levels
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: anemia; chronic kidney disease; CKD; chronic renal insufficiency; renal impairment; erythropoietin; safety; efficacy; tolerability; pharmacokinetics

Summary:

      The purpose of this study is to evaluate the safety, pharmacodynamics and pharmacokinetics of
      repeat doses of orally administered AKB-6548 in pre-dialysis participants with anemia.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  18 to 79 years of age, inclusive

          -  Chronic Kidney Disease Stage 3 or Stage 4

          -  Hemoglobin (Hgb) < 10.5 g/dl

          -  TSAT > 20% and CBC indicating normocytic red blood cell morphology

        Key Exclusion Criteria:

          -  BMI > 40

          -  Red blood cell transfusion within 12 weeks.

          -  Androgen therapy within the previous 21 days prior to study dosing

          -  Therapy with any approved or experimental erythropoiesis stimulating agent (ESA)
             within the 10 weeks prior to the Screening visit

          -  Participants meeting the criteria of ESA resistance within the previous 4 months

          -  Individual doses of intravenous iron of 250 mg or larger within the past 21 days

          -  AST or ALT >1.8x ULN.

          -  Alkaline phosphatase >2x ULN.

          -  Total bilirubin >1.5x ULN.

          -  Uncontrolled hypertension

          -  New York Heart Association Class III or IV congestive heart failure

          -  Myocardial infarction, acute coronary syndrome, or stroke within 6 months prior to
             dosing
Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome
Condition: Neonatal Abstinence Syndrome
MeSH terms: Neonatal Abstinence Syndrome; Syndrome
Intervention: Phenobarbital; Clonidine
Intervention description: Phenobarbital loading dose 20 mg/kg in 2 divided doses, then 5 mg/kg/day divided every 12 hours. Phenobarbital dose will be adjusted to obtain desired trough of 25 to 30 mcg/mL. Levels will be obtained on Day 6 then weekly thereafter. Phenobarbital will be tapered over 4 weeks upon discharge from the hospital. The standardized taper is based the patient specific dose at the time of discharge.; Clonidine 5 mcg/kg/day divided every 3 hours. Clonidine will be increased by 1.5 mcg/kg/day to achieve control of NAS symptoms based upon standardized scoring for neonatal abstinence syndrome. Clonidine will be weaned by 25% every 24 hours after successful discontinuation of oral morphine sulfate. Infants will not be discharged on clonidine.
Intervention MeSH terms: Clonidine; Phenobarbital
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 35 Weeks
Healthy volunteers: No

Summary:

      The purpose of this study is to compare clonidine versus phenobarbital as adjunctive therapy
      in those infants who have failed monotherapy with morphine sulfate for neonatal abstinence
      syndrome (NAS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infants greater than or equal to 35 weeks gestation age

          -  Admitted to the neonatal intensive care unit

          -  Failed monotherapy with morphine sulfate therapy

        Exclusion Criteria:

          -  Neonatal abstinence syndrome due to iatrogenic causes

          -  Unable to take oral medications at any point during their treatment

          -  Infants in the custody of the Department of Child Protective Services with no legal
             guardian identified at the time of enrollment
Smoking, Sex Hormones, and Pregnancy
Condition: Nicotine Dependence; Contraception
MeSH terms: Tobacco Use Disorder
Intervention: Low-dose Progesterone; High-dose Progesterone
Intervention description: The "low" progesterone dose is seven days of placebo Tri-sprintec + placebo generic Prometrium twice a day (7AM and 7PM).; The "high" progesterone dose is seven days of placebo Tri-Sprintec + 200mg of generic Prometrium twice a day (7AM and 7PM).
Intervention MeSH terms: Progesterone
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 95.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The investigators aim to (1) examine the association between levels of progesterone (Prog),
      allopregnanolone (Allo), and the estradiol/progesterone (E2/P) ratios with smoking-related
      symptomatology during ad libitum smoking and (2) determine the association between Prog,
      Allo, and E2/P with the changes in smoking-related symptomatology and response to nicotine
      following overnight abstinence
    

Eligibility criteria:

        Inclusion Criteria:

          -  currently taking oral contraceptives

          -  English fluency

          -  Ability to provide informed consent

        Exclusion Criteria:

          -  use of progestin only contraceptive

          -  pregnancy
Imaging GABAergic/Glutamatergic Drugs in Bipolar Alcoholics Alcoholics
Condition: Alcohol Use Disorder; Bipolar Disorder
MeSH terms: Alcoholism; Bipolar Disorder
Intervention: N-Acetylcysteine; Gabapentin; Placebo Oral Tablet
Intervention description: 5 day trial of N-acetylcysteine with titration to 2,400mg; 5 day trial of gabapentin with titration to 1,200mg; 5 day trial of matched placebo
Intervention MeSH terms: Acetylcysteine; Gabapentin; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-Blind
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The proposed 3-week, double-blind, crossover, proof of concept study aims to manipulate
      neurochemical dysfunctions characteristic of individuals with co-occurring BD and AUD (i.e.,
      abnormally low prefrontal GABA and glutamate), using medications that have been shown to
      normalize cortical GABA (i.e., gabapentin) and glutamate (i.e., NAC) levels in past research,
      and to evaluate medication-related changes in response inhibition and alcohol cue-reactivity
      fMRI tasks as well as drinking and mood in individuals with AUD+BD.
    

Eligibility criteria:

        Inclusion:

          -  Meets DSM-V diagnostic criteria for Bipolar Disorder

          -  Using at least one mood stabilizing medication

          -  Meets diagnostic criteria Alcohol Use Disorder, with active drinking in the past
             month.

        Exclusion:

          -  Serious medical or non-inclusionary psychiatric disease

          -  Concomitant use of benzodiazepine medications or any medications hazardous if taken
             with gabapentin/N-acetylcysteine

          -  History of clinically significant brain injury

          -  Presence of non-MRI safe material, or clinically significant claustrophobia.
Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Type II Refractory Celiac Disease
Condition: Type II Refractory Celiac Disease (RCD-II); In-situ Small Bowel T-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Celiac Disease
Intervention: AMG 714; Placebo
Intervention description: Administered via a 120-minute IV infusion for a total of 7 times over 10 weeks.; Administered via a 120-minute IV infusion for a total of 7 times over 10 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Protocol CELIM-RCD-002 is designed to evaluate the efficacy and safety of AMG 714 for the
      treatment of adult patients with type II refractory celiac disease (RCD-II), an in-situ small
      bowel T-cell lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of refractory celiac disease Type II (RCD-II)

          -  Greater than 20% aberrant intraepithelial lymphocytes (IEL) as assessed by flow
             cytometry

          -  On a gluten-free diet for at least 6 months

          -  Avoid pregnancy

        Exclusion Criteria:

          -  Enteropathy-Associated T cell Lymphoma (EATL)

          -  Infections

          -  Immune suppression

          -  Clinically significant co-morbidities
Nigella Sativa in COVID-19
Condition: COVID-19; SARS-CoV-2
MeSH terms: COVID-19
Intervention: Nigella sativa oil
Intervention description: Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized, open-label, controlled clinical study
Masking: None (Open Label)
Enrollment: 183.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: COVID-19; SARS-CoV-2; Nigella sativa; Herbal

Summary:

      Natural products with immunomodulation and antiviral activity showed a promising improvement
      in the outcomes of some viral infectious diseases both in preclinical and primitive clinical
      studies. The aim of this study is to utilize Saudi FDA licensed Nigella sativa (NS) seed oil
      towards improving disease outcomes in adult patients diagnosed with mild COVID-19. The study
      will be a prospective, open-label, non-randomized controlled pilot trial. Patients will be
      supplemented (add-on) with one capsule of black seed oil twice daily for 10 days. The primary
      outcome will be the proportion of patients who clinically recovered on day 14. The secondary
      outcomes will be clinical parameters and routine laboratory tests. If encouraging outcomes
      occurred, NS supplementation may be recommended as an add-on to standard care protocol to
      enhance the recovery from COVID-19 disease in the current emerging situation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with mild COVID19 upper respiratory tract infection and with no evidence of
             pneumonia

          -  Adult (18 Years and above)

          -  Written informed consent prior to initiation of any study procedures by the patient
             (or legally authorized representative).

          -  Understands and agrees to comply with planned study procedures.

          -  Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by
             polymerase chain reaction (PCR) available at KAUH.

        Exclusion Criteria:

          -  Patients with pneumonia or severe illness requiring admission to ICU.

          -  Severe chronic kidney disease (i.e. estimated glomerular filtration rate (eGFR) < 30)
             or end stage renal disease requiring dialysis

          -  Sever chronic liver disease (Alanine transaminase/aspartate transaminase (ALT/AST) > 5
             times the upper limit of normal).

          -  Pregnancy or breast feeding.

          -  Anticipated transfer to another hospital which is not a study site within 72 hours.

          -  Allergy to any study medication.
A Study to Evaluate the Safety and Immunogenicity of Inactivated Varicella Zoster Virus (VZV) Vaccine in Adults With Autoimmune Disease (V212-009)
Condition: Herpes Zoster
MeSH terms: Herpes Zoster; Autoimmune Diseases
Intervention: V212; Placebo
Intervention description: V212 viral antigen for HZ; Placebo comparator to V212 vaccine
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 354.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Shingles

Summary:

      This is a study to evaluate the safety and immunogenicity of V212 vaccine in adults with
      autoimmune disease, including participants with rheumatoid arthritis, psoriatic arthritis,
      psoriasis, inflammatory bowel disease, systemic lupus erythematosus, multiple sclerosis, and
      other similar diseases. The primary hypothesis is that vaccination with V212 vaccine will
      elicit significant VZV-specific immune responses at approximately 28 days after vaccination
      4. The statistical criterion for significance requires that the lower bound of the 2-sided
      95% confidence interval of the geometric mean fold rise in vaccine recipients is >1.0.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with an autoimmune disease

          -  Clinically stable disease for at least 30 days before enrollment

          -  Not likely to undergo hematopoietic stem cell transplantation during the study period

          -  Receiving at least one parenteral or oral biologic agent, such as a Tumor Necrosis
             factor (TNF) alpha inhibitor, or a parenteral or oral non-biologic therapy, at a
             stable dose for at least 3 months, with no planned or anticipated changes

          -  History of varicella, antibodies to VZV, or residence for at least 30 years in a
             country with endemic VZV infection, or if participant is less than 30 years old,
             attended primary or secondary school in a country with endemic VZV infection

        Exclusion Criteria:

          -  Prior history of Herpes Zoster (shingles) within 1 year before enrollment

          -  Prior varicella or zoster vaccine

          -  Active central nervous system lupus erythematosus requiring therapeutic intervention
             within 90 days of enrollment

          -  Prior or planned therapy containing rituximab or other anti-Cluster of Differentiation
             (CD) 20 monoclonal antibodies from 3 months before enrollment through 28 days postdose
             4

          -  Systemic corticosteroid therapy, prednisone, or equivalent over 40 mg daily at the
             time of enrollment