bioihbjkbjnl/mcl2 huggingface dataset:
An Extension Study of V203-AD Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of UB-311
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: UB-311; Placebo
Intervention description: Intramuscular injection; Intramuscular injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: All
Minimum age: 60 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      To evaluate the long-term safety, tolerability and potential efficacy, patients who
      previously participated in V203-AD study (NCT02551809) will be eligible to participate in the
      extension study and will receive 3 or 5 doses of UB-311 within a 96-week treatment period
      followed by a 12-week follow-up period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who participated in V203-AD trial without major safety concerns;

          -  Stable doses of permitted medications for 3 months before screening;

          -  With a caregiver;

          -  Other inclusion criteria apply

        Exclusion Criteria:

          -  Clinically significant neurological disease other than Alzheimer's disease

          -  Major psychiatric disorder

          -  Severe systemic disease

          -  Serious adverse reactions to any vaccine

          -  Other exclusion criteria apply
Periarticular Injection Versus Peripheral Nerve Block in Total Hip Arthroplasty
Condition: Hip Arthropathy
MeSH terms: Joint Diseases
Intervention: Nerve Block; Periarticular Injection (PAI); Ropivacaine; Dex
Intervention description: Nerve blocks (QLB/LFCNB) to be placed preoperatively with DEX/MPA, per standard of care of anesthesia block service.
QLB: 40ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA
LFCNB: 20ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA; Intraoperatively, the surgeon will perform PAI per standard of care with the medications:
1. 60 ml 0.2% ropivacaine and 10 mg DEX/ 80 mg MPA; 60 ml 0.2% ropivacaine; 10 mg DEX/ 80 mg MPA
Intervention MeSH terms: Ropivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 192.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess if preoperative quadratus lumborum block (QLB)/lateral femoral
      cutaneous nerve block (LFCNB) with ropivacaine and glucocorticoids provide more effective
      analgesia than periarticular injection (PAI) with the same mixture in total hip arthroplasty
      (THA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Elective unilateral primary THA

          -  All surgical approaches

          -  American Society of Anesthesiologist (ASA) status I, II and III.

        Exclusion Criteria:

          -  Patient refusal;

          -  Age less than 18 years

          -  Those with cognitive dysfunction, psychiatric disorder, or non-English speaking
             patients that cannot consent or communicate clear understanding of the protocol with
             research team;

          -  Coagulopathy;
Pharmacological Treatment of Rett Syndrome With Glatiramer Acetate (Copaxone)
Condition: Rett Syndrome
MeSH terms: Rett Syndrome; Syndrome
Intervention: Glatiramer Acetate
Intervention MeSH terms: Glatiramer Acetate; (T,G)-A-L
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: Female
Minimum age: 10 Years
Healthy volunteers: No
Keywords: Treatment trial, Rett syndrome, Glatiramer acetate

Summary:

      A phase 2 open label trial to test a potential drug treatment for Rett syndrome, the leading
      known genetic cause of severe neurological impairment in girls. The drug, Copaxone (generic
      name - Glatiramer acetate) is medication FDA approved for the treatment of multiple
      sclerosis. Copaxone's high safety profile has been documented in large cohorts of patients
      for more than 12 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female patients with genetically confirmed Rett Syndrome (RTT)

          -  Age: 10 or more years old. Selection of the age is based on the available evidence of
             the safety of Glatiramer Acetate (GA) in this group, and the relative
             homogeneity/stability of the phenotype, which is not expected to spontaneously change
             within a 6 month period at this age

          -  Ambulatory (with our without support)

        Exclusion Criteria:

          -  Prolonged Qtc (obtained within 30 days prior to enrollment)

          -  Presence of co morbid non-Rett related disease

          -  Presence of immunodeficiency requiring intravenous immunoglobulin 3 (IVIG 3) months
             prior to enrollment

          -  Allergy/sensitivity to GA or mannitol

          -  Inability or unwillingness of legal guardians to give written informed consent
Effect of Banaba (Lagerstroemia Speciosa) on Metabolic Syndrome, Insulin Secretion and Insulin Sensitivity
Condition: Metabolic Syndrome X
MeSH terms: Metabolic Syndrome; Insulin Resistance; Hypersensitivity; Syndrome
Intervention: Banaba; placebo
Intervention description: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.; Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg
Intervention MeSH terms: Magnesium Oxide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 30 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Metabolic syndrome; central obesity; Banaba; insulin secretion; insulin sensitivity

Summary:

      The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult
      population suffers the disease.

      Banaba has shown evidence that has on metabolic syndrome, insulin sensitivity and insulin
      secretion.

      The investigators hypothesis was that the the administration of resveratrol modifies the
      metabolic syndrome, insulin sensitivity and insulin secretion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients both sexes,

          -  Age between 30 and 60 years,

          -  Metabolic Syndrome according to the IDF criteria

          -  Waist circumference

          -  Man ≥90 cm

          -  Woman ≥80 cm

        And two of the following criteria:

          -  High density lipoprotein

          -  Man ≤40 mg/dL

          -  Woman ≤50 mg/dL

          -  Fasting glucose ≥100 mg/dL

          -  Triglycerides ≥150 mg/dL

          -  Blood pressure ≥130/85 mmHg

          -  Informed consent signed

        Exclusion Criteria:

          -  Women with confirmed or suspected pregnancy

          -  Women under lactation and/or puerperium

          -  Hypersensibility to resveratrol

          -  Physical impossibility for taking pills

          -  Known uncontrolled renal, hepatic, heart or thyroid diseased

          -  Previous treatment for the metabolic syndrome components

          -  Body Mass Index ≥39.9 kg/m2

          -  Fasting glucose ≥126 mg/dL

          -  Triglycerides ≥500 mg/dL

          -  Total cholesterol ≥240 mg/dL

          -  Low density lipoprotein (c-LDL) ≥190 mg/dL

          -  Blood Pressure ≥140/90 mmHg
The Use of Dexmedetomidine for EEG Sedation in Children With Behavioural Disorders
Condition: Procedural Sedation; Behavior Disorders
MeSH terms: Mental Disorders
Intervention: dexmedetomidine
Intervention description: To administer dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Drug administration by a loading dose followed by continuous infusion during a procedure
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 1 Month
Maximum age: 18 Years
Healthy volunteers: No
Keywords: dexmedetomidine; sedation

Summary:

      Children's compliance during diagnostic or therapeutic procedures is a challenge, often
      requiring the use of sedative and/or analgesic drugs.

      Electroencephalogram (EEG) needs stillness for a medium-long period but, at the same time,
      the use of any drug for sedation may affect the exam through an interference with EEG waves.
      Dexmedetomidine is a selective ∝2-adrenergic agonist with sedative and anxiolytic properties,
      with a long effect and which does not alter EEG pattern.

      The aim of this interventional study is to evaluate the effectiveness, safety and feasibility
      of dexmedetomidine for sedation during EEG in children who are not cooperative.

      Children affected by behavioral disorders and requiring sedation to perform EEG were
      considered. The protocol establishes to administer IV dexmedetomidine (loading dose and
      continued infusion) to reach a targeted level of sedation (Pediatric Sedation State Scale =
      2). Vital signs (SatO2, RR, EtCO2, HR, BP) and level of sedation are recorded before, during
      and after procedure until the offset.
    

Eligibility criteria:

        Inclusion Criteria:

          -  children affected by behavior disorders who underwent EEG procedure with sedation

          -  written informed consent

        Exclusion Criteria:

          -  ASA > 2

          -  hypersensitivity of active substance

          -  therapy with beta blockers or digoxin, arrhythmia
Exploratory Trial to Assess the Functionality of an Integrated Call Center for the Digital Medicine System
Condition: Schizophrenia; Major Depressive Disorder; Bipolar I Disorder
MeSH terms: Schizophrenia; Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Aripiprazole + IEM (Ingestible Event Marker)
Intervention description: Oral aripiprazole (2, 5, 10, 15, 20, or 30 mg) with an ingestible event marker in a single daily dose for duration of the trial.
Intervention MeSH terms: Aripiprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will assess the helpfulness of the integrated call center in optimizing use of the
      Digital Medicine System in adult subjects with Schizophrenia, Major Depressive Disorder, or
      Bipolar Disorder taking oral aripiprazole.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary diagnosis of Schizophrenia (SCH), Major Depressive Disorder (MDD), or Bipolar
             1 Disorder (BP1), per the Diagnostic and Statistical Manual of Mental Disorders, Fifth
             Edition (DSM-5)

          -  Must be able to swallow tablets

          -  Currently taking a stable daily dose of oral aripiprazole

          -  Must have capacity to utilize the technology

          -  Skin in area of patch application must be free of any skin disorders or dermatological
             problems

        Exclusion Criteria:

          -  Subjects using long acting injectable antipsychotic medications

          -  Subjects likely to be incapable of using the Digital Medicine System even with
             assistance

          -  Subjects who present serious risk of suicide

          -  History of epilepsy or seizures

          -  History of hypersensitivity to antipsychotic agents, adhesive tape or any component of
             the sensor skin patch or ingestible event marker

          -  Current history of substance use disorder meeting DSM-5 criteria

          -  Subject with unstable mood, acute psychosis or exhibiting symptoms requiring
             hospitalization
Open-label, Multiple Ascending Dose Study of Ravulizumab (ALXN1210) in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Condition: Paroxysmal Nocturnal Hemoglobinuria; PNH
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Intervention: Ravulizumab
Intervention description: All treatments were given as IV infusions.
Intervention MeSH terms: Ravulizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: complement inhibitor

Summary:

      The primary purpose of this study is to evaluate the safety, tolerability, and efficacy of
      multiple intravenous (IV) doses of ravulizumab administered to complement inhibitor
      treatment-naïve participants with PNH.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female ≥18 years of age

          2. PNH diagnosis confirmed by documented high-sensitivity flow cytometry

          3. Documented meningococcal vaccination not more than 3 years prior to dosing

          4. Female participants of childbearing potential were to use highly effective
             contraception starting at screening and continuing until at least 8 months after the
             last dose of ravulizumab.

          5. Willing and able to give written informed consent and comply with the study visit
             schedule

        Exclusion Criteria:

          1. Treatment with a complement inhibitor at any time

          2. Female participants who are planning to become pregnant, or are pregnant,
             breastfeeding or who had a positive pregnancy test at screening or Day 1

          3. Participation in an interventional clinical study within 30 days before initiation of
             dosing on Day 1, or use of any experimental therapy within 30 days prior to dosing on
             Day 1, or within 5 half-lives of the investigational product, whichever was greater

          4. History of allergy to any drug, allergen, excipients of ravulizumab or known allergy
             to Chinese hamster ovary cell proteins

          5. Inability to comply with study requirements

          6. History of any clinically significant cardiac, hepatic, immunologic, pulmonary, or
             rheumatoid disease that, in the Investigator's judgment, would preclude participation

          7. Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make
             the participant unsuitable for enrollment
Evaluation the Treatment of Tamoxifen of Low/Intermediate Risk Bladder Tumors
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Intervention: Tamoxifen Citrate
Intervention description: Single-center, two-stage phase-II clinical trial (Simon design)
Intervention MeSH terms: Tamoxifen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Tamoxifen citrate; Bladder Cancer

Summary:

      Evaluate the treatment of tamoxifen of low/intermediate-risk bladder tumors
    

Eligibility criteria:

        Inclusion Criteria:

        Males and females age 21 or older. Histologic evidence of urothelial carcinoma of the
        bladder. Low/Intermediate-risk papillary urothelial carcinoma of the bladder, at initial
        occurrence or recurrent with >6 months interval free of disease.

        Patients with multifocal tumors must have resectable lesions. Patients may be
        treatment-naïve or have failed 1 previous regimen of intravesical therapy.

        At least one endoscopically measurable tumor 6 - 10mm in diameter. Adequate hepatic and
        renal function. Patient or authorized proxy needs to have signed the informed consent form.

        -

        Exclusion Criteria:

        Patients with sessile appearing tumors, which may be invasive or high-grade. Diagnosis of
        urothelial carcinoma involving the prostatic urethra or upper urinary tract.

        Plans for pelvic radiation while participating in the study. Concurrent use of warfarin,
        heparin, or chronic use of NSAIDs, including aspirin (other than cardioprotective doses of
        80mg daily) within 30 days prior to registration or during the trial.

        Concurrent use of selective serotonin reuptake inhibitors or aromatase inhibitors.

        Chronic or acute renal or hepatic disorder or any other condition, medical or psychological
        that, in the opinion of the investigator, could jeopardize the subject's safe
        participation.

        Any other investigational drug within 30 days prior to registration and during the study.

        Women Exclusion Pregnant or lactating women. Personal history of endometrial cancer or any
        abnormal uterine bleeding. Previous or concurrent treatment with SERM and/or hormonal
        replacement therapy within 3 months of the study.

        -
Evaluation of the Use of Trental and Vitamin E For Prophylaxis of Radiation Necrosis
Condition: Brain Metastasis
MeSH terms: Neoplasm Metastasis; Brain Neoplasms; Necrosis
Intervention: Trental; Vitamin E
Intervention description: 400 mg tid starting first day after last radiosurgery treatment and continuing for 6 months; 400IU twice daily starting the first day after last radiosurgery treatment and continuing for 6 months
Intervention MeSH terms: Vitamin E; Pentoxifylline
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: brain metastasis

Summary:

      The purpose of this study is to determine whether the use of Trental and Vitamin E can help
      reduce the incidence of radiation necrosis (a lesion that usually occurs at the original
      tumor site) after radiosurgery. These two drugs are commonly used to treat radiation necrosis
      when it occurs but the hope is that these drugs can be used to prevent radiation necrosis
      from ever occurring.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Plan to undergo single or five fraction radiosurgery for a metastatic brain tumor

          -  Diagnosis of a metastatic brain tumor may be accomplished by histologic confirmation
             or by clinical confirmation by the treating physician based on MR imaging
             characteristics in the setting of a known history of cancer

          -  Age > 18 years

          -  Partial or total resection of a metastatic tumor are eligible

        Exclusion Criteria:

          -  Known sensitivity to vitamin E or Trental

          -  Recent intracranial bleed or retinal hemorrhage

          -  Treatment with a non-approved or investigational drug within 30 days before day 1 of
             study treatment

          -  History of Avastin treatment

          -  Anticipated need for treatment with Avastin

          -  History of bleeding disorder

          -  History of liver disorder
Donor Lymphocyte Infusion With Azacitidine to Prevent Hematologic Malignancy Relapse After Stem Cell Transplantation
Condition: Acute Myelogenous Leukemia; Acute Lymphoid Leukemia; Juvenile Myelomonocytic Leukemia; Myelodysplastic Syndrome
MeSH terms: Leukemia; Preleukemia; Leukemia, Myeloid; Hematologic Neoplasms; Leukemia, Myeloid, Acute; Leukemia, Lymphoid; Leukemia, Myelomonocytic, Juvenile; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic Syndromes
Intervention: azacitidine; donor lymphocyte infusion
Intervention description: 40mg/m2 IV/SC daily x 4 days, maximum of 7 cycles at 6 weekly intervals; For patients with cells available for DLI who are in the high risk group and do not have graft-versus-host disease (GVHD), DLI will be adminstered on day 5 of each cycle.
Intervention MeSH terms: Azacitidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Maximum age: 29 Years
Healthy volunteers: No
Keywords: pediatric leukemia myelodysplastic syndrome azacitidine

Summary:

      The goal of this study is to determine whether post-transplant consolidation with azacitidine
      combined with donor lymphocyte infusion (DLI) is a safe and effective approach for the
      prevention of relapse in pediatric and young adult patients with hematologic malignancies who
      have undergone hematopoietic stem cell transplantation (HSCT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients age 0 - 29.9 years undergoing allogeneic peripheral blood stem cell
             transplant

          -  Patients with acute myelogenous leukemia (AML) or acute lymphoblastic leukemia (ALL)

          -  Patients with juvenile myelomonocytic leukemia (JMML)

          -  Patients with myelodysplastic syndrome (MDS)

        Exclusion Criteria:

          -  Patients who have had a prior transplant.

          -  Patients with Fanconi anemia or other cancer-predisposition syndromes

          -  Patients with expected survival <12 weeks

          -  Lansky score <60%