bioihbjkbjnl/mcl2 huggingface dataset:
Retrospective Analysis for Patients With Hemophagocytosis in Bone Marrow
Condition: Hemophagocytosis
Study type: Observational

Summary: 
      Comparison of malignant and non-malignant disorders associated bone marrow hemophagocytosis.
    

Detailed description: 
      This is a retrospective study comparing malignant and non-malignant disorders associated bone
      marrow hemophagocytosis. The medical record of patients who had documented evidences of
      hemophagocytosis in bone marrow are reviewed. The clinical and biological characteristics are
      compared according to the underlying disorders of hemophagocytosis.
    

Intervention name(s): Hemophagocytosis
Intervention type(s): Other
Intervention description(s): Best supportive care and immunosuppressive treatments
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The investigators reviewed the electronic data base of medical records at the Samsung
        Medical Center, and selected 264 patients who had evidence of hemophagocytic histiocytosis
        in bone marrow aspiration and biopsy between January 2000 and June 2014.
Safety and Blood Donations in Adults Vaccinated With rMenB+OMV NZ.
Condition: Meningitis, Meningococcal, Serogroup B
MeSH terms: Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to assess the safety of a Meningococcal Group B Vaccine and to
      collect blood donation. Sera panel obtained from blood donations will be used as a control to
      measure the immunoresponse to the Meningococcal Group B Vaccine in other studies.
    


Intervention name(s): Meningococcal (group B) multicomponent recombinant adsorbed vaccine
Intervention type(s): Biological
Intervention description(s): One dose (0.5 mL) vaccine administered by intramuscular (IM) injection in the deltoid area of the non-dominant arm.
Other intervention name(s): rMenB+OMV NZ
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Desaturation Validation of INVSENSOR00009
Condition: Healthy
Study type: Interventional

Summary: 
      This study is designed to measure the trending accuracy of a noninvasive measurement of
      cerebral oxygen saturation. One Large sensor (adult sensor) and one INVSENSOR00009 will be
      placed on the subject's forehead. The values obtained by the INVSENSOR00009 will be compared
      to the values collected with the adult sensor.Data will be collected from healthy adult
      subjects while undergoing a desaturation procedure wherein the concentration of oxygen
      inhaled is slowly reduced until the subject's arterial oxygen saturation is approximately
      70%. The subject will then be returned to inhaling room air.
    


Intervention name(s): INVSENSOR00009
Intervention type(s): Device
Intervention description(s): All subjects who are enrolled into the test group and participate in data collection receive both the INVSENSOR00009 and the control sensor simultaneously on the forehead.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Determine the Bioequivalence of Two Formulations of Hyoscine Butylbromide.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Determine bioequivalence of two forumulations with hyoscine butylbromide 10mg sugar coated
      tablets.
    


Intervention name(s): hyoscine butylbromide
Intervention type(s): Drug
Intervention MeSH terms: Scopolamine; Butylscopolammonium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
AAB-001 in Patients With Mild to Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and tolerability of multiple doses of
      AAB-001 passive immunization in patients with mild to moderate Alzheimer's disease (AD).
    

Detailed description: 
      The humanized monoclonal antibody, AAB-001, which binds to and clears beta amyloid peptide,
      is designed to provide antibodies to beta amyloid directly to the patient, rather than
      requiring the patient to mount his/her own individual response. It is believed that this
      approach may eliminate the need for the patient to mount an immune response to beta amyloid.
      Animal studies have shown that this approach is equally effective in clearing beta amyloid
      from the brain as traditional active immunization methods.

      This is a multicenter, double-blind, placebo controlled, randomized, outpatient, multiple
      ascending dose study in male and female patients aged 50 to 85 years with mild to moderate
      AD. Approximately 30 study sites will be involved. Patients will be randomized to receive
      either AAB-001 or placebo. Each patient's participation will last approximately 2 years.
    

Intervention name(s): bapineuzumab; placebo
Intervention type(s): Drug; Other
Intervention description(s): IV, Q13w; IV Q13w
Other intervention name(s): AAB-001
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer's disease; immunotherapy; beta amyloid
Efficacy of tACS for Treatment of Auditory Hallucinations in Refractory Schizophrenia
Condition: Schizophrenia
MeSH terms: Hallucinations; Schizophrenia; Schizophrenia, Treatment-Resistant
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the feasibility and efficacy of transcranial alternating
      current stimulation (tACS) as an add-on treatment for auditory hallucinations in refractory
      schizophrenia. Meanwhile, we aim to evaluate the effect of tACS on cognitive function of
      schizophrenia patients. we hypothesize tACS would improve refractory auditory hallucination
      symptoms in schizophrenia by regulating the gamma frequency band of temporal lobe。
    

Detailed description: 
      This is a randomized, double-blind, sham-controlled study to detect the effect of tACS for
      treatment of refractory auditory hallucinations in schizophrenia. 50 participants were
      randomly assigned 1:1 to tACS group or sham-control group. For both active and sham group,
      daily tACS sessions were scheduled in a 5-day sequence for four consecutive weeks, and each
      session lasted 20minutes. Based on the original and stable medication, active participants
      were administered 2 mA alternating current delivered with gamma frequency, delivered over the
      temporal lobe, while controls received sham stimulations with the same protocol. Scale
      assessments are performed at baseline, week 2, week 4 and week 6. Collection of blood took
      place at baseline, week 4 and week 6.
    

Intervention name(s): Transcranial alternating Current Stimulation (tACS)-active; Transcranial Alternating Current Stimulation (tACS)-sham
Intervention type(s): Device; Device
Intervention description(s): Transcranial alternating current stimulation (tACS) employs a weak electric current for non-invasive brain stimulation with a sine-wave waveform, targeting brain oscillations in a frequency-specific manner. daily tACS sessions were scheduled in a 5-day sequence for four consecutive weeks, and each session lasted 20minutes. Participants were administered 2 mA alternating current delivered with gamma frequency, delivered over the temporal lobe.; Transcranial alternating current stimulation (tACS) employs a weak electric current for non-invasive brain stimulation with a sine-wave waveform, targeting brain oscillations in a frequency-specific manner. Controls received sham stimulations with the same protocol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Efficacy and Tolerance of WR279,396 for Old World Cutaneous Leishmaniasis
Condition: Old World Cutaneous Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2 study is to determine whether WR279396 with occlusion (a polyurethane dressing)
      is more effective than WR279396 without occlusion for once daily treatment.

      Extensive objective and subjective local tolerance data will also be captured during this
      trial, as well as surrogate markers (parasite loads and aminoglycosides concentration in the
      deep dermis) that may help to determine the optimal number and duration of treatments.

      The results from this study will help determine the most practical treatment schedule and
      will answer questions that are crucial to improve the present treatment regimen with WR279396
      which is twice a day for 20 days.
    

Detailed description: 
      Forty-eight patients (48) with Old World cutaneous leishmaniasis will be randomly allocated
      to WR279396 treatment once a day for 20 days with an optimized polyurethane dressing
      (occlusion) (24 patients), or without occlusion (24 patients). All patients will be rescued
      with the standard of care accepted in Tunisia, if the patient is not cured. The active
      ingredients of WR279396 are two aminoglycosides - paromomycin sulphate (15%) and gentamicin
      sulphate (0.5%) - in a base (AQIC).

      Each subject will be followed for clinical cure for 90 days after the initiation of
      treatment. Cure is defined as 100% reepithelialization without relapse by 3 months.

      Tolerance will be evaluated by local adverse reactions and by laboratory signs of systemic
      events.

      In addition to the clinical evaluation of the CL lesions, the following parameters/clinical
      healing surrogates will be investigated:

        1. parasite load will be determined in superficial and deep lesional dermis samples at D0
           and D10. The mean parasite reduction ratio (parasite load at D10/parasite load at D0) in
           each group will be compared;

        2. aminoglycoside concentrations in superficial and deep infiltrated dermis in each group
           will be compared.
    

Intervention name(s): WR279,396 with Tegaderm Dressing; WR 279,396 with Gauze and Tape Dressing
Intervention type(s): Drug; Drug
Intervention description(s): Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days with polyurethane dressing; Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ointment to treat leishmania skin lesions
The Effects of the Anesthetic Ketamine in Young Children Undergoing Procedural Sedation
Condition: Trauma
Study type: Observational

Summary: 
      In the emergency department (ED), ketamine is a popular anesthetic agent during sedation of
      children for painful and other short procedures. Sedation for procedures is more commonly
      used in children than adults, to achieve motion control and cooperation. In children,
      ketamine offers an ideal choice due to the fact that it is short acting, a highly effective
      sedative, and preserves cardio-respiratory stability. In the United States, more than one
      million children per year up to four years of age undergo short procedures requiring
      anesthestic agents, including ketamine. However, there is mounting concern from animal
      studies and retrospective human research regarding the safety of ketamine when administered
      to infants and young children with respect to its potential toxic effects on the developing .
      Conversely, ketamine has also been suggested as a neuroprotective agent. Prompt investigation
      and resolution of this issue is urgently required.
    

Detailed description: 
      The objectives of this study are:

      Primary Objective: In otherwise healthy children between 3 and 48 months of age who present
      to a tertiary care emergency department and receive procedural sedation with ketamine, to
      determine if there is at least a 50% increase, compared to baseline in the serum
      concentration of any of the neurotoxicity biomarkers S100B, glial fibrillary acidic protein
      (GFAP) or neuronal-specific enolase (NSE), 1 to 3 hours after intravenous ketamine
      administration. The cut-off of 50% is a benchmark value routinely quoted in both animal and
      human studies, which correlated neurotoxicity biomarker levels with functional outcomes.

      Secondary Objectives: In the aforementioned population:

        1. To determine if at least a 50% increase in the serum concentration of S100B, GFAP or NSE
           compared to baseline at 6 to 12 hours after intravenous ketamine administration.

        2. To explore if genotypes relevant to ketamine metabolism and disposition are associated
           with increased vulnerability to the neurotoxic effects of ketamine.

        3. To determine the toxic effect of ketamine administration at the cellular level (evidence
           of sustainable cellular damage and mitochondrial DNA changes).
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All children between the ages of 3 and 48 months who receive intravenous ketamine for
        procedural sedation in the ED during study enrolment hours will be eligible for
        recruitment.
      
Biospecimen description: 
      Blood and plasma samples
    
Keywords: sedation; children; infants; ketamine; neurotoxicity
A Comparison of Two Daily Disposable Soft Contact Lenses
Condition: Visual Acuity
Study type: Interventional

Summary: 
      Approximately 120 subjects will be comparing two soft contact lenses for one week each.
    


Intervention name(s): senofilcon A; delefilcon A
Intervention type(s): Device; Device
Intervention description(s): Subjects will wear the contact lenses in both eyes for seven days; Subjects will wear the contact lenses in both eyes for seven days
Other intervention name(s): senofilcon A Prototype; Dailies Total 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Reducing Edema Following Refractive Surgery
Condition: Edema
MeSH terms: Edema
Study type: Observational

Summary: 
      Determine if edema plays a role in refractive surgery
    

Detailed description: 
      Prospective, comparative study
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        At least 10 subjects following laser refractive procedure
      
Keywords: Refractive surgery
Vitamin D Supplementation in Glomerular Disease
Condition: Glomerular Disease
Study type: Interventional

Summary: 
      This multi-site, pilot study will assess vitamin D supplementation in children and young
      adults with Glomerular Disease. .
    

Detailed description: 
      Vitamin D deficiency has been linked to a variety of adverse health outcomes. Nephrotic
      patients have very low vitamin D levels, and the underlying mechanisms are not known.
      Furthermore, approaches to safely and effectively supplement vitamin D in these patients have
      not been established. The purpose of this research study is to learn if vitamin D
      supplementation is safe and effective in patients with primary glomerular disease and to also
      help establish the treatment guidelines. About 35 patients with primary glomerular disease,
      ages 5-30 years old, will take part in this study. Participants will be asked to take vitamin
      D supplements each day for 12 weeks and will have 3 study visits.
    

Intervention name(s): Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeks
Intervention type(s): Dietary Supplement
Intervention description(s): Supplements will be provided as oral capsules.
Other intervention name(s): Vitamin D
Intervention MeSH terms: Vitamin D; Cholecalciferol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glomerular Disease; Vitamin D; Steroid-resistant nephrotic syndrome; Minimal change disease; Focal segmental glomerulosclerosis (FSGS); Membranous Nephropathy; Membranoprolfierative Glomerulonephritis; immunoglobulin A (IgA) Nephropathy; FSGS; IgA Nephropathy
Phase I Study to Evaluate Bioavailability of Overencapsulated Celecoxib
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I study designed to test the hypothesis that overencapsulated celecoxib 200 mg qd is
      bioequivalent to commercial celecoxib 200 mg qd. Approximately 90 healthy volunteers will be
      randomized to yield approximately 80 completers. The study is an open label, randomized,
      2-way crossover with single dosing followed by a 7-day washout period between treatment arms
    


Intervention name(s): celecoxib
Intervention type(s): Drug
Intervention description(s): dose form
Other intervention name(s): Celebrex
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Phase I,; Healthy; Volunteer; Study
Prevention of Low Blood Pressure in Persons With Tetraplegia
Condition: Hypotension; Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Quadriplegia; Hypotension
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this investigation is to determine the blood pressure response to NOS inhibition,
      with L-NAME, in persons with tetraplegia compared to non-SCI control subjects and to
      establish if blood pressure can be increased while upright in those with tetraplegia. If
      blood pressure is increased with NOS inhibition in persons with tetraplegia, this would
      improve our treatment of the condition of low blood pressure during seated postures in
      individuals with tetraplegia.
    

Detailed description: 
      Despite disruption of central command of the vasculature during orthostatic maneuvers,
      individuals with tetraplegia are generally able to be seated in an upright position for long
      periods of time without developing symptoms of orthostatic intolerance. It must be
      appreciated however, that orthostatic hypotension may occur unpredictably in persons with
      chronic tetraplegia. This may result in a range of symptoms due to cerebral hypoperfusion
      from mild reduction in mental acuity to loss of consciousness. Nitric oxide (NO) is the most
      potent endogenous vasodilator which is synthesized by the enzyme NO synthase (NOS) and may be
      largely responsible for orthostatic hypotension in individuals with immobilizing conditions.
      Recent evidence suggests an up-regulation of inducible nitric oxide synthases (NOS) activity
      with prolonged exposure to hind limb suspension. The effects of NOS inhibition during
      orthostasis on blood pressure regulation in those with chronic tetraplegia may provide
      insight into effective pharmacological therapy to reduce or prevent pathologic orthostatic
      changes. Treatment with a NOS inhibitor may facilitate the process of mobilization in those
      with acute higher cord lesions.
    

Intervention name(s): N-Nitro L-arginine-methylester (L-NAME); Head-up Tilt maneuver
Intervention type(s): Drug; Procedure
Intervention description(s): A non-specific inhibitor of the nitric oxide synthase enzyme.; Participant will be placed onto tilt table and brought to 15 degrees of head up tilt for 60 minutes (intravenous infusion time). After this time, a progressive increase to 45 degrees will be completed with a 10 degree increase every 5 minutes. Participant will remain at 45 degrees for 45 minutes or until symptom onset.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Blood Pressure; Cardiovascular Autonomic Control; Nitric Oxide; NOS Inhibitor; Orthostatic Hypotension; Spinal Cord Injury; Tetraplegia
Prevalence of Latent Tuberculosis (TB) Infection Diagnosed by Interferon-gamma Release Assay and Tuberculin Skin Tests in Patients With Old Healed TB
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Observational

Summary: 
      We easily regard nodules and fibrosis in upper lobes of lung as TB sequelae. The aim of this
      study is to confirm the prevalence of latent TB infection diagnosed by interferon-gamma
      release assay and tuberculin skin tests in patients with old healed TB.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with TB sequelae in their CXR
      
Keywords: People who have fibrosis or nodules in their upper lobe of the lung
A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-H3733 in Subjects With Chronic Hepatitis B Virus Infection
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Virus Diseases; Herpesviridae Infections; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, blinded, placebo-controlled, dose-ranging Phase 1b study of the safety,
      PK, and antiviral activity of ABI-H3733 in treatment-naïve or off-treatment chronic Hepatitis
      B virus (cHBV) subjects that are Hepatitis B e antigen (HBeAg) positive or negative. The
      study will enroll up to 5 sequential cohorts of 10 subjects each, for a total of up to 50
      subjects, randomized 8:2 to receive ABI-H3733 or placebo.
    


Intervention name(s): ABI-H3733; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg or 100 mg tablets for oral administration; 25 mg or 100 mg tablets for oral administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: cHBV; HBV; Hepatitis B