bioihbjkbjnl/mcl2 huggingface dataset:
Essential Oils for Enhancing QOL in ASD
Condition: Autism Spectrum Disorder; Quality of Life; Sleep; Anxiety
MeSH terms: Autism Spectrum Disorder
Intervention: Reconnect; Coconut oil Comparator
Intervention description: Topical Essential Oils mixture and aromatic method; Topical Essential Oils mixture and aromatic method
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 3 Years
Maximum age: 9 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Relaxation

Summary:

      Essential oils (aromatic oils extracted from plant parts) are routinely used by the public
      and are available on the market. Investigators are conducting this study because it is
      unknown whether the essential oils formulations will be safe and effective for improving
      quality of life in children with Autism Spectrum Disorder (ASD) by helping them relax and
      sleep.

      Children invited to participate in this study must be between 3-9 years of age and have been
      diagnosed with Autism Spectrum Disorder. Twenty eight children and their families will be
      enrolled in the study.

      Participants will try two different fragrant oils in a double-blind randomized order. Each
      child will receive each treatment for 3 months, with a 1-month "washout" period in between
      during which no oil is used.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatients between 3 and 9 years of age, inclusive;

          -  Diagnosis of Autism Spectrum Disorder (ASD) by DSM-V;

          -  Mean item score of > or = 1.5 PedsQL Inventory;

          -  Care provider who can reliably bring subject to clinic visits and provide trustworthy
             ratings.

        Exclusion Criteria:

          -  Bipolar disorder by Child & Adolescent Symptom Inventory (CASI, Gadow & Sprafkin,
             1997) and clinical interview/history, or major depression accompanied by family
             history of bipolar disorder;

          -  Children with allergies to essential oils;

          -  Children with seizure disorder/epilepsy;

          -  Significant physical illness (e.g., serious cardiovascular, liver or renal pathology);

          -  Medications specifically given for insomnia and exogenous melatonin, which have the
             potential to confound study results, within the previous 2 weeks before baseline;

          -  Anticipated changes of doses of medication or other medical treatments or supplements;

          -  Weight less than 10 kg;

          -  Sleep Disordered Breathing (SDB) as defined by a total score of > or = 3 on the CSHQ
             SDB subscale and parent report;

          -  Nut allergies;

          -  Allergy to vanilla;

          -  A substantial trial of essential oil use within the past 6 months (i.e., consistent
             use for 6 weeks).
ITI-007 (Lumateperone Tosylate) for Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: ITI-007
Intervention description: ITI-007 (Lumateperone tosylate)dosed 40-60 mg based on efficacy/adverse events
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: open-label
Masking: None (Open Label)
Masking description: None (open label)
Enrollment: 4.0
Sex: Male
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to offer open label ITI-007 treatment to patients who poorly
      respond or poorly tolerate approved medications.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) diagnosis
             of schizophrenia or schizoaffective disorder

          -  Has capacity to provide informed consent

          -  Medically stable for study participation

          -  Judged clinically not to be at significant suicide or violence risk

          -  Inadequate response or tolerability to previously antipsychotic therapy, as defined by
             at least one of the following: prior clozapine failure, a PANSS>80 despite at least
             six weeks of a current antipsychotic therapy, a Clinical Global Impressions
             scale-Improvement (CGI-I) of 4 after at least two six week trials of antipsychotics
             (retrospective assessment) or failure to tolerate an adequate dose of at least
             antipsychotics (as defined by the Physicians Desk Reference)

        Exclusion Criteria:

          -  Substance abuse within last 90 days

          -  ECG abnormality that is clinically significant

          -  Pregnancy, lactation, or lack of use of effective birth control

          -  Presence or positive history of significant unstable medical or neurological illness
             (including any history of seizure disorder, hepatitis, renal insufficiency or mental
             retardation), history of HIV

          -  Clinically significant abnormal laboratory tests, positive for hepatitis B or C or
             liver function tests (LFTs) > 2x Upper Limit of Normal, use of strong CYP3A4
             inhibitors or inducers

          -  History or presence of concomitant major psychiatric illness.

          -  Use of other antipsychotic medications at baseline.

          -  Use of another investigational medication in the previous 4 weeks
TLC399 (ProDex) in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO)
Condition: Retinal Vein Occlusion; Macula Edema
MeSH terms: Macular Edema; Retinal Vein Occlusion; Edema
Intervention: TLC399 (ProDex)
Intervention description: 2-vial system: TLC399-DSP and TLC399-Lipid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Randomized, double-masked trial designed to investigate the use of TLC399 (ProDex) in
      subjects with macular edema due to CRVO or BRVO.
    

Eligibility criteria:

        Inclusion Criteria:

          1. male or female, at least 18 years of age

          2. macular edema due to CRVO or BRVO

          3. best-corrected visual acuity (BCVA) score of 20/40 to 20/400

          4. mean central subfield thickness (CST) ≥350 um

          5. willing and able to comply with the study procedure and sign a written informed
             consent

          6. agree to use a medically acceptable form of birth control

        Exclusion Criteria:

          1. poorly controlled diabetes

          2. history of significant intraocular pressure (IOP) elevation to steroid treatment

          3. history of ocular hypertension and glaucoma

          4. cataract surgery in the study eye within 3 months, or intraocular surgery within 6
             months prior to screening

          5. use of hemodilution for the treatment of RVO

          6. use of IVT ranibizumab or bevacizumab in the study eye within 6 weeks prior to
             screening; or IVT aflibercept within 8 weeks prior to screening

          7. IVT Ozurdex to the study eye within 6 months prior to screening

          8. prior use of Retisert or Iluvien

          9. use of systemic steroids or heparin within 1 month prior to screening
A Phase 2 Study of SYM-1219 to Treat Bacterial Vaginosis
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Intervention: SYM-1219; Placebo
Intervention description: Oral; Oral
Intervention MeSH terms: Secnidazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 215.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to test the safety and effectiveness of the oral
      investigational new drug, SYM-1219, for the treatment of bacterial vaginosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are females at least 18 years of age in good general health who are not menopausal.

          -  Have a clinical diagnosis of bacterial vaginosis, defined as having all of the
             following criteria:

          -  Off-white (milky or gray), thin, homogeneous vaginal discharge

          -  Vaginal pH ≥ 4.7

          -  Presence of clue cells of ≥ 20% of the total epithelial cells on microscopic
             examination of the vaginal saline wet mount

          -  A positive 10% KOH Whiff test.

          -  Have a Gram stain slide Nugent score ≥ 4 at the Baseline visit (Day 1)

        Exclusion Criteria:

          -  Are pregnant, lactating, or planning to become pregnant during the study.

          -  Are suspected clinically (or confirmed diagnostically) of having alternative causes of
             vaginal symptoms including candidiasis, Chlamydia trachomatis, Trichomonas vaginalis,
             Neisseria gonorrhoeae or Herpes simplex.

          -  Have received antifungal or antimicrobial therapy (systemic or intravaginal) within 14
             days prior to the Baseline visit (Day 1).
16-Week Repeat Oral Dose Study of AKB-6548 for Anemia in Participants With End Stage Renal Disease (ESRD) Requiring Chronic Hemodialysis
Condition: Anemia; End Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Anemia
Intervention: AKB-6548; AKB-6548; AKB-6548
Intervention description: Starting dose 1. Oral dose administered once daily for 16 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.; Starting dose 2. Oral dose administered once daily for 16 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.; Starting dose 3. Oral dose administered three times weekly for 16 weeks. Dose adjustment based on hemoglobin levels as defined in the protocol.
Intervention MeSH terms: Glycine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 94.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: anemia; end stage renal disease; chronic kidney disease; CKD; dialysis; chronic renal insufficiency; renal impairment; erythropoietin; kidney; oral anemia treatment; hemoglobin; hypoxia-inducible factor; HIF; hypoxia-inducible factor propyl-hydroxylase inhibitor; HIF-PHI; pharmacokinetics

Summary:

      The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and
      tolerability of orally administered AKB-6548 in participants with end stage renal disease
      undergoing chronic hemodialysis.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  18 to 79 years inclusive

          -  Chronic Kidney Disease (CKD) Stage 5 on chronic hemodialysis for at least 3 months

          -  Anemia secondary to CKD treated with erythropoiesis stimulating agent and intravenous
             iron

        Key Exclusion Criteria:

          -  Body mass index >44.0 kilograms per meter squared (kg/m^2)

          -  Transfusion within 8 weeks prior to Screening

          -  Alanine transaminase or total bilirubin >1.25x ULN

          -  Uncontrolled hypertension

          -  Class III or IV congestive heart failure

          -  Myocardial infarction, acute coronary syndrome, stroke or transient ischemic attack
             within 6 months prior to Screening
A Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa.
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: Bimekizumab; Adalimumab; Placebo
Intervention description: Bimekizumab in different dosages (dose 1 and 2).; Adalimumab in different dosages (dose 1, 2 and 3).; Placebo will be provided matching Bimekizumab.
Intervention MeSH terms: Adalimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hidradenitis Suppurativa; Bimekizumab; HS; Moderate to Severe HS

Summary:

      Hidradenitis suppurativa (HS) is a painful, long-term skin condition that causes abscesses
      and scarring on the skin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult subjects (18 to 70 years of age, inclusive) must have a diagnosis of HS for at
             least

             1 year prior to Baseline

          -  Stable HS for at least 2 months prior to Screening and also at the Baseline Visit

          -  Inadequate response to at least a 3-month study of an oral antibiotic for treatment of
             HS

          -  Total abscess and inflammatory nodule count >=3 at the Baseline Visit

          -  Subject must agree to daily use (and throughout the entirety of the study) of 1
             pre-specified over-the-counter topical antiseptics on their HS lesions

          -  Female subjects must be postmenopausal, permanently sterilized or, if of childbearing
             potential, must be willing to use a highly effective method of contraception up till
             20 weeks after last administration of study drug and have a negative pregnancy test at
             Visit 1 (Screening) and immediately prior to first dose

          -  Male subjects must be willing to use a method of contraception when sexually active,
             up till 20 weeks after the last administration of study medication

        Exclusion Criteria:

          -  Prior treatment with anti-IL17s or participation in an anti-IL17 study

          -  Previously received anti-TNFs

          -  Subject requires, or is expected to require, opioid analgesics for any reason
             (excluding tramadol)

          -  Subject received prescription topical therapies for the treatment of HS within 14 days
             prior to the Baseline Visit

          -  Subject received systemic non-biologic therapies for HS with potential therapeutic
             impact for HS less than 28 days prior to Baseline Visit

          -  Draining fistula count >20 at the Baseline Visit

          -  Diagnosis of inflammatory conditions other than HS
A Study to Evaluate SAGE-217 in Participants With Essential Tremor
Condition: Essential Tremor
MeSH terms: Tremor; Essential Tremor
Intervention: SAGE-217; SAGE-217; Placebo
Intervention description: SAGE-217 Oral Solution; SAGE-217 Capsules; SAGE-217 matching placebo capsules
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Tremor

Summary:

      This study is a three-part, multicenter, Phase 2a study to evaluate the efficacy, safety,
      tolerability, and pharmacokinetics of SAGE-217 in adult participants with essential tremor.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Participant must have a diagnosis of Essential Tremor (ET), defined as bilateral
             postural tremor and kinetic tremor, involving hands and forearms, that is visible and
             persistent and the duration is >5 years prior to screening.

        Key Exclusion Criteria:

          -  Participant has presence of abnormal neurological signs other than tremor or Froment's
             sign.

          -  Participant has presence of known causes of enhanced physiological tremor.

          -  Participant has concurrent or recent exposure (14 days prior to admission visit) to
             tremorogenic drugs.

          -  Participant has had direct or indirect trauma to the nervous system within 3 months
             before the onset of tremor.

          -  Participant has historical or clinical evidence of tremor with psychogenic origin.

          -  Participant has convincing evidence of sudden tremor onset or evidence of stepwise
             deterioration of tremor.
Medtronic Reveal XT Study
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Reveal XT implantation
Intervention description: The implantation of the Reveal XT device will be performed at the time of surgery before the planned median sternotomy or thoracotomy.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Patients

Summary:

      While surgical treatment for atrial fibrillation (AF) has been performed for over 20 years,
      virtually all of the historical series reported only the recurrence of symptomatic AF and
      have used only intermittent electrocardiogram (ECG) follow-up. This study compares the use of
      traditional arrhythmia assessment (ECG and 24-hour holter monitoring) with the use of the
      Medtronic Reveal XT device to continuously record heart rhythm to quantify postoperative
      arrhythmia burden following surgical treatment for AF in patients undergoing either lone or
      concomitant heart surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients undergoing planned, elective AF surgery, either as a stand-alone procedure or
             as a concomitant cardiac operation.

          2. Patients will have either a Cox-Maze procedure (full-biatrial lesion set) or surgical
             pulmonary vein isolation (PVI).

          3. Patients 18 years or older.

          4. All eligible patients will be considered, regardless of gender or race.

          5. Patients able and willing to provide informed consent and willing to comply with the
             required interval follow-up.

        Exclusion Criteria:

          1. Patients with a preoperative permanent pacemaker.

          2. Patients with a projected lifespan of less than six months.

          3. Patients requiring emergent cardiac surgery.

          4. Patients unwilling or unable to give written informed consent.

          5. Patients undergoing a right atrial or left atrial lesion set procedure.
Hematopoietic Stem Cell Transplantation (HSCT) for Children With SCID Utilizing Alemtuzumab, Plerixafor & Filgrastim
Condition: Severe Combined Immunodeficiency
MeSH terms: Severe Combined Immunodeficiency; Immunologic Deficiency Syndromes
Intervention: Transplant Conditioning with Mobilization Only; Transplant Conditioning with Mobilization and Alemtuzumab
Intervention description: Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0 Transplant; Day -7: Alemtuzumab 0.3 mg test dose then 0.3 mg/kg IV; Day -6: Alemtuzumab 0.3 mg/kg IV; Day -5: Alemtuzumab 0.3 mg/kg IV; Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0: Transplant
Intervention MeSH terms: Plerixafor; Alemtuzumab; Lenograstim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Maximum age: 3 Years
Healthy volunteers: No
Keywords: SCID; Transplant; Alemtuzumab; Plerixafor

Summary:

      The goal of this study is to develop a novel approach to hematopoietic stem cell
      transplantation for children with Severe Combined Immunodeficiency Disease (SCID) that
      eliminates the use of toxic chemotherapy conditioning and maximizes the likelihood of T and B
      cell immune reconstitution. Rather than classic chemotherapeutic agents, the investigators
      will utilize a targeted stem cell mobilizer, plerixafor, in combination with alemtuzumab, a
      monoclonal antibody. Correlative scientific questions will include: 1) efficacy and
      characteristics of host stem cell mobilization; and 2) alemtuzumab pharmacokinetics in very
      young children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with classic SCID phenotype (<400 CD3/ul or maternally engrafted and <10% of
             normal PHA lymphoproliferative response). Genotypic identification is preferable, but
             not required.

          -  Patients must have an acceptable stem cell donor (HLA matched relative, 9 or 10/10
             HLA-matched unrelated, or haplocompatible relative).

        Exclusion Criteria:

          -  Patients with "leaky" SCID syndromes, Omenn's Syndrome, reticular dysgenesis, ADA
             deficiency

          -  Lansky score <60%

          -  Patient with expected survival <4 weeks (including disseminated CMV infection
             involving lungs and/or CNS)