bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy, Safety, Pharmacokinetics and Immunogenicity Study of Abatacept Administered Intravenously to Treat Active Polyarticular-course Juvenile Idiopathic Arthritis in Japan
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy of Abatacept after intravenous
      administration in Japanese children and adolescents with active juvenile idiopathic arthritis
      who have a history of an inadequate response or intolerance to Methotrexate or biologics
    


Intervention name(s): Abatacept
Intervention type(s): Drug
Other intervention name(s): BMS-188667; ONO-4164
Intervention MeSH terms: Abatacept
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Improving Visual Attention in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      This study investigates whether visual attention can be improved in individuals with
      schizophrenia by stimulating the brain via transcranial Direct Current Stimulation (tDCS).
    

Detailed description: 
      Individuals with schizophrenia tend to display abnormal visual attention when performing
      visual tasks, typically spending less time on salient features of the stimuli (e.g. core
      facial features or body movement in social tasks), and instead focusing on idiosyncratic
      features of an image or video. Poor visual attention in schizophrenia has been directly
      linked to poorer social cognitive performance (e.g. recognizing emotional expressions or
      social cues) which can impact an individual's day to day functioning.

      Transcranial Direct Current Stimulation (tDCS) is a form of noninvasive neurostimulation
      which has been proposed as a therapeutic procedure in numerous psychiatric disorders. TDCS in
      schizophrenia has been demonstrated to improve a wide range of cognitive processes, and in
      healthy adults, tDCS has been demonstrated to improve aspects of social cognition. TDCS thus
      appears to be a promising therapeutic technique that may be useful for improving visual
      attention in patients with schizophrenia, and potentially impact social cognitive performance
      via an underlying mechanism tying the two. This study will compare visual performance in
      individuals with schizophrenia across two conditions: active anodal tDCS and sham tDCS, while
      also comparing between brain stimulation sites: rTPJ and dmPFC.
    

Intervention name(s): Active anodal tDCS; Sham tDCS
Intervention type(s): Device; Device
Intervention description(s): active anodal tDCS with behavioral tasks to assess visual attention; sham tDCS with behavioral tasks to assess visual attention
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will be paired based on key demographic criteria and assigned to one of two stimulation locations (rTPJ or dmPFC), participants will then complete active and sham stimulation sessions in a randomized, counterbalanced order approximately one week apart.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
A Clinical Study Evaluating Inhaled Aviptadil on COVID-19
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a multicenter, prospective, placebo-controlled, comparative, randomized,
      double-blind local phase II clinical trial. Duration of study is 18 months. In the study,
      patients will be randomized in a ratio of 1: 1 into two arms, standard medical therapy +
      placebo versus standard medical therapy + inhaled Aviptadil arms. Randomization will be
      carried out by the block randomization method. In the event that patients need intensive care
      in the study, the patients will be taken into intensive care unit and excluded from the study
      and their treatment will be continued in the intensive care unit as deemed appropriate by the
      physician and it is foreseen that inhaled Aviptadil will be used for a period of minimum 7
      and maximum 14 days. Aviptadil will be discontinued in patients who do not heal after 14
      days. This study includes 8 visits, consisting of a total of 7 physical visits and 1 phone
      follow-up visit. The study period will be 6 months for each patient. Patient recruitment is
      planned to take 12 months. Study centers will be asked to use investigational products for
      their patients who sign the informed consent form for 12 months. The study population will
      consist of patients 18 years of age and older with COVID-19 pulmonary involvement and
      hospitalized patients.
    


Intervention name(s): Inhaled Aviptadil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Aviptadil is the synthetic analogue of the Vasoactive Intestinal Peptide (VIP), a biologically active 28 amino acid natural peptide that is endogenously synthesized in humans. It is one of the signaling molecules of the neuroendocrine immune network and has vasodilator, anti-proliferative, anti-inflammatory and immunomodulatory properties.; Aviptadil Placebo will be used for this arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In the study, patients will be randomized in a ratio of 1: 1 into two arms, standard medical therapy + placebo versus standard medical therapy + inhaled Aviptadil arms. Randomization will be carried out by the block randomization method.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Aviptadil; Inhaled; COVID-19; Pandemic
A Follow-up Study on Safety and Tolerability of Intracerebroventricular Administration of sNN0031 to Patients With Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      The purpose of this study is to document the long-term safety and tolerability after
      intracerebroventricular (ICV) administration of sNN0031 (PDGF-BB) in patients who
      participated in study sNN0031-001
    


Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with idiopathic PD of moderate severity who have completed participation
        in study sNN0031-001.
Effect of Extra- Fine Versus Coarse-Particle Inhaled Corticosteroids (ICS) on Ventilation Heterogeneity in Children With Poorly Controlled Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of the study is to show that ventilation heterogeneity identified by
      hyperpolarized helium-3 lung MRI is prevalent children with poorly controlled asthma despite
      guidelines-based treatment with ICS. The secondary objective is to demonstrate whether or not
      eight weeks of treatment with extra-fine particle ICS (HFA-BDP) improves ventilation
      heterogeneity compared to treatment with a coarse particle ICS (fluticasone HFA or dry
      powder).
    


Intervention name(s): beclomethasone; fluticasone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Fluticasone; Beclomethasone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Bipolar Transcranial Alternating Current Stimulation (tACS)
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      The purpose of this clinical trial is to measure the safety and effectiveness of a
      non-invasive brain stimulation device called Transcranial Alternating Current Stimulation
      (tACS) in participants with bipolar disorder (BD).

      Participants will be asked to come in for 3 sessions. If participants qualify at the
      screening visit (session 1) then enrolled participants will complete sessions 2 and 3 as well
      as have a 30-day follow-up phone call.
    


Intervention name(s): tACS brain stimulation treatment; Sham stimulation treatment
Intervention type(s): Device; Device
Intervention description(s): Participants will wear an EEG cap on the head attached with EEG-recording and tACS electrodes. tACS will be delivered by passing a small electrical current via the tACS electrodes to the scalp to stimulate brain activity during a computerized behavioral task. The effect of active stimulation on EEG will be measured via EEG-recording electrodes during short rests (between stimulation blocks). The stimulation session will last for approximately 60 minutes. After treatment, participants will be asked about the experience and if there are any side effects.; Participants will wear an EEG cap on the head attached with EEG-recording and tACS electrodes. Sham tACS will be delivered by passing a transient (approximately 12 seconds ) small electrical current via the tACS electrodes during a computerized behavioral task. The effect of sham stimulation on EEG will be measured via EEG-recording electrodes during short rests (between stimulation blocks). The sham stimulation session will last for approximately 60 minutes. After treatment, participants will be asked about the experience and if there are any side effects.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: transcranial alternating current stimulation (tACS); electroencephalogram (EEG)
Carboplatin in Treating Patients With Recurrent High-Grade Gliomas
Condition: Adult Anaplastic Astrocytoma; Adult Anaplastic Oligodendroglioma; Recurrent Adult Brain Tumor
MeSH terms: Glioma; Astrocytoma; Oligodendroglioma; Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being done to evaluate the toxicity and safety of carboplatin administered by
      convection enhanced delivery into the tumor in patients with high grade glial neoplasms. This
      study is a dose escalating study, (the dose of the study drug is increased at set time
      points). Carboplatin is in a class of drugs known as platinum-containing compounds; it slows
      or stops the growth of cancer cells in your body. Convection enhanced delivery involves
      placing one or more catheters into the brain and delivering chemotherapy through those
      catheters directly into the brain
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Establish the maximum tolerated dose and define the toxicity profile of carboplatin
      delivered intracerebrally via convection enhanced delivery (CED) for patients with high grade
      glial neoplasms.

      SECONDARY OBJECTIVES:

      I. Examine the efficacy as defined by six-month progression free survival (PFS), median
      progression free survival, overall survival, and the radiographic response rate.

      II. Evaluate the drug distribution.

      OUTLINE: This is a phase I, dose-escalation study.

      Patients undergo craniotomy and then receive carboplatin intracerebrally via
      convection-enhanced delivery (CED) over 72 hours.
    

Intervention name(s): carboplatin; Surgery
Intervention type(s): Drug; Procedure
Intervention description(s): Carboplatin in a volume of 54 ml will be administered intracerebrally by convection enhanced delivery; Patients will undergo surgery, which includes tumor resection and catheter placement, in the operating room.
Other intervention name(s): Carboplat; CBDCA; JM-8; Paraplat; Paraplatin; craniotomy
Intervention MeSH terms: Carboplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gliomas; Carboplatin
An Extension Study to Assess the Long-Term Safety and Efficacy of Pasireotide in Participants With Acromegaly
Condition: Acromegaly
MeSH terms: Acromegaly
Study type: Interventional
Phase: Phase 2

Summary: 
      Acromegaly is a rare, serious condition characterized by chronic hypersecretion of growth
      hormone (GH), generally caused by a GH-secreting pituitary adenoma. The study assessed the
      long-term safety and efficacy of pasireotide in participants with acromegaly.
    


Intervention name(s): Pasireotide
Intervention type(s): Drug
Other intervention name(s): SOM230
Intervention MeSH terms: Pasireotide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acromegaly; Pasireotide; GH; IGF-1
Minimally Invasive Micro Sclerostomy: Safety and Preliminary Performance Study
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      Eligible Glaucoma patients will undergo pre-surgery examination including:

      medicines list, blood tests and ECG. On surgery day: intraocular pressure (IOP) will be
      measured. Then a sub-conjunctival injection of Mitomycin C will be administered .

      The Minimally Invasive Micro Sclerostomy (MIMS) procedure is designed to create a drainage
      channel at the sclera-corneal junction by penetrating through the wall [scleral tissue] .
      MIMS procedure may be combined with cataract surgery.

      Patients will be followed up to 24 weeks post operation.
    

Detailed description: 
      Eligible patients will have ECG and blood test up to 30 days prior to the MIMS procedure.

      Description of MIMS procedure:

      on surgery day, intraocular pressure (IOP) will be measured. Then a sub-conjunctival
      injection of Mitomycin C will be administered .

      creating drainage channel at the sclera-corneal junction by penetrating through the wall
      [scleral tissue].MIMS procedure may be combined with cataract surgery.

      Post-operatively the patient will be treated with dexamethasone-neomycin drops for at least
      one month.

      Patients will be followed up to 24 weeks post operation.

      The following measurements will be included:

        -  Intra Ocular Pressure (IOP)

        -  Best Corrected Visual Acuity (BCVA)

        -  Slit Lamp Biomicroscopic evaluation

        -  Anterior Segment Optical coherence tomography (OCT)

        -  Fundus Examination
    

Intervention name(s): Minimally Invasive Micro Sclerostomy (MIMS)
Intervention type(s): Device
Intervention description(s): The System is a surgical device, designed to create a drainage channel at the sclera-corneal junction . The drainage channel is created by a Stainless Steel surgical tool.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Safety of Tetravalent Rotavirus Vaccine in Healthy Indian Adult Male Volunteers
Condition: Rotavirus Gastroenteritis
MeSH terms: Gastroenteritis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I study to evaluate the safety and tolerability of the tetravalent rota virus
      vaccine in healthy Indian adult male volunteers administered a single dose of the vaccine at
      the highest possible viral concentration in 0.5 mL of vaccine.
    


Intervention name(s): Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine (BRV-TV); Placebo
Intervention type(s): Biological; Other
Intervention description(s): Single dose (0.5 mL) of the vaccine administered orally; Single dose (0.5 mL) of the placebo administered orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Safety of vaccine
Routine Preoperative Evaluation in Surgical Patient
Condition: Orthopedic Disorder
MeSH terms: Musculoskeletal Diseases
Study type: Observational

Summary: 
      The "routine" pre-operative tests in healthy orthopaedic patients undergoing intermediate/
      major surgery are not justified. In this study of 670 healthy orthopedic patients with 7610
      preoperative tests, investigators found that surgical plan was influenced in <1% of patients.
      Surgeons should be sensitized to reconsider this practice particularly with limited
      resources.
    

Detailed description: 
      Background: Routine preoperative tests in healthy patients not only cause extra anxiety, but
      may delay treatment without influencing surgical plan. This has worse impact in
      resource-constrained settings where fee for service rather than health insurance is the usual
      norm. Investigators aim to determine if "routine" pre-operative tests are justified in
      healthy orthopedic patients.

      Methods: Investigators conducted a non-commercialized, non-funded matched case control study
      in tertiary care university hospital and a level-1 trauma centre for healthy patients
      (ASA-1&2) admitted from January 2014-December 2016 for elective orthopedic intermediate and
      major procedures. Cases (patient who had a change in his/her surgical plan after admission)
      and controls were selected independently of the exposure of interest then matched randomly to
      cases on age, gender and procedure type. Primary exposure was the routine preoperative lab
      tests, as defined by the American Society of Anesthesiologist, which included 13 blood tests.
      Analysis was done using Principle Component Analysis and Conditional logistic regression at
      univariate and multivariable levels reporting matched adjusted Odds Ratios. The data will
      bereported in line with STROBE criteria.

      .
    

Intervention name(s): preoperative blood tests
Intervention type(s): Other
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients irrespective of age and gender who were classified as ASA-1 and ASA-2 by the
        anesthesia team and who underwent minor, intermediate and major primary elective orthopedic
        procedures
      
Keywords: preoperative evaluation; orthopedic surgery
Safety and Hemodynamic Effects and Pharmacokinetics of CXL-1020 in Patients With Stable Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A Phase 1-2a Study of CXL-1020-01 in Patients with Stable Heart Failure
    

Detailed description: 
      This is a Phase I/IIa Dose-Escalation, First exposure in Humans, Study Evaluating the Safety
      and Tolerability of CXL-1020 and Specific Effects on Electrocardiographic and Non-Invasive
      Hemodynamic Parameters in Patients with Chronic Heart Failure. 4 weekly four-hour treatments
      involving ascending dosages of CXL-1020 with a randomly interspersed placebo dose within two
      or more unique patient cohorts. Separate echocardiography cohorts (Echo Cohort A and Echo
      Cohort B) will evaluate a sustained dose over 4 hours (ECHO A), and an ascending two dose
      level, 4-hour infusion (2 hours each) (ECHO B), in individual patients. Echo Cohort dosages
      will be determined from responses observed in previous cohort exposures.
    

Intervention name(s): CXL-1020; CXL-1020; Placebo for CXL-1020 Cohort 1; Placebo for CXL-1020 Cohort 2; CXL-1020 Dose for Echo Cohort A; CXL-1020 Doses for Echo Cohort B
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Intravenous infusion of one of 3 active dosages of CXL-1020; Intravenous infusion of one of 3 active dosages of CXL-1020 at dosages higher than in Cohort 1; A 4 hour infusion of a IV solution containing 5% Dextrose in water (Sugar Water); A 4 hour infusion of a IV solution containing 5% Dextrose in water (Sugar Water); A 4 hour fixed dose of CXL-1020 which was studied in Cohort 1 or 2 which was demonstrated to be safe and well tolerated and have some anticipated hemodynamic effect; A 2 hour dose level of CXL-1020 which was studied in Cohort 1 or 2 which was demonstrated to be safe and well tolerated and have some anticipated hemodynamic effect followed by another higher 2 hour dose level of CXL-1020 which was studied in Cohort 1 or 2 which was demonstrated to be safe and well tolerated and have some anticipated hemodynamic effect
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heart Failure
Anti-inflammatory Effect of Therapeutic Hypothermia in Out-hospital Cardiac Arrest Patients With Cardiogenic Shock
Condition: Cardiac Arrest
MeSH terms: Heart Arrest; Shock, Cardiogenic; Hypothermia
Study type: Interventional

Summary: 
      Acute myocardial infarction complicated with cardiogenic shock trigger IL-6, the strong
      inflammatory response, result in multiple organ failure, even death.

      While therapeutic hypothermia,to expect the possibility of anti-inflammatory effect via IL-6
      bi-phasic effect and IL-10 , to improve the multiple organ failure, to increase survival rate
      and well cerebral performance.
    

Detailed description: 
      Despite emergency coronary revascularization coupled with medical stabilization, intra-aortic
      balloon pump have significantly improved survival in patients with cardiogenic shock
      complicating acute myocardial infarction, mortality still remains excessively high, being
      actually about 30-50%. Future research should focus on new therapeutic strategies, aimed to
      further decrease mortality rate of these patients or improve possible hospitalization and
      prognosis.

      Heart pumping failure result in cardiogenic shock. Increased LA filling pressure result in
      acute pulmonary edema, hypoxemic respiratory failure, even congestive kidney and congestive
      liver. Decreased stroke volume result in hypoperfusion obviously direct induce acute renal
      failure, disturbance consciousness and lactate accumulation, even, shock liver. Multiple
      organ failure is the major mortality in the patients suffered from cardiogenic shock after
      acute myocardial infarction.

      Cardiogenic shock remains the leading cause of death in patients hospitalized for myocardial
      infarction . Systemic inflammation , especially endovascular Interleukin-6, triggered by
      Tumor necrosis factor-alfa and Interleukin-1 beta result in inappropriate vasodilatation is
      observed in many patients with cardiogenic shock and may contribute to an excess mortality
      rate. In recent study, interleukin-6 represented a reliable independent early prognostic
      marker of 30-day mortality.

      Therapeutic hypothermia (34℃) increase stroke volume, reduce muscle oxygen consumption and
      enhance anti-inflammatory action . The mechanism of anti-inflammatory effect for therapeutic
      hypothermia in cardiogenic shock is still unclear, need to further study in clinical trial.
      Furthermore, this study will provide new strategy to increase survival rate in cardiogenic
      shock.
    

Intervention name(s): Therapeutic hypothermia group
Intervention type(s): Device
Intervention description(s): Therapeutic hypothermia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute myocardial infarction, cardiogenic shock