bioihbjkbjnl/mcl2 huggingface dataset:
State Dependent Resonance in the BG-cortical Loops
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Neuronal activity in circuits between the basal ganglia (BG) and motor cortical areas is
      abnormally synchronized and rhythmic. The oscillatory activity prevails at 8-30 Hz in
      untreated Parkinson's Disease (PD) and its amplitude at both subthalamic and cortical levels
      inversely correlates with motor impairment. Moreover, these different levels in BG-cortical
      loops are coherent in this frequency band. The 8-30 Hz activity is suppressed by treatment
      following treatment with dopaminergic drugs and is partially suppressed prior to and during
      voluntary movements. An unanswered question is how do BG-cortical loops become so prominently
      engaged in this oscillatory activity? One possible explanation is that the resonance
      frequencies of the loops fall in the 8-30 Hz band in the untreated state, so that
      oscillations in this band are transmitted particularly well. So we hypothesize loop
      resonances in the 8-30 Hz frequency band at rest, which should be suppressed during movement
      and following dopaminergic therapy.
    

Detailed description: 
      Stimulate STN (at 0, 5, 10, 15, 20, 25, 30, 40, 70 and 130 Hz) in chronically implanted
      patients at rest and during simple and complex motor tasks while recording the steady state
      evoked potential over the cortex using EEG over the 19 sites of the classical 10/20 system
      and a channel to record artifact over the stimulator. Experiments will be carried out both in
      the OFF medication and ON medication condition.
    

Intervention name(s): electrostimulation
Intervention type(s): Procedure
Intervention description(s): Stimulate STN (at 0, 5, 10, 15, 20, 25, 30, 40, 70 and 130 Hz) in chronically implanted patients at rest and during simple and complex motor tasks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: parkinson
Prevention of Complications of Eye Surgery
Condition: Strabismus
MeSH terms: Strabismus
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was designed to investigate pre-operatively measured parameters of various
      anaesthetic regimes, iris color, sex, age, surgical time, severity of Marcus-Gunn Pupil
      (MGP), type of mechanical stimulation of eye, and number of extraocular muscle (EOM) under
      tension as predictors of significant OCR in pediatric strabismus surgery.
    

Detailed description: 
      Objectives: Despite various proposed maneuver, successfully predicting an oculocardiac reflex
      (OCR) is difficult to achieve. This study was designed to investigate pre-operatively
      measured parameters of various anaesthetic regimes, iris color, sex, age, surgical time,
      severity of Marcus-Gunn Pupil (MGP), type of mechanical stimulation of eye, and number of
      extraocular muscle (EOM) under tension as predictors of significant OCR in pediatric
      strabismus surgery.

      Methods: Three hundred patients were randomized to one of three anesthetic regimes: group P:
      propofol (2 mg/kg), alfentanil 0.02 mg/kg, and atracurium 0.5 mg/kg at induction; group K:
      ketamine (2mg/kg), alfentanil 0.02 mg/kg, and atracurium 0.5 mg/kg at induction; group T:
      thiopental (5mg/kg), alfentanil 0.02 mg/kg, and atracurium 0.5 mg/kg at induction. OCR was
      defined as a 10% change in heart rate induced by traction.

      Results: Incidence of OCR was significantly lower in patients in group k compared with
      patients in group T or P. Chi-square test results showed that the occurrence of OCR was
      significantly associated with difference of iris color (P=0.01). The occurrence of the OCR
      did not correlate with sex, age, duration of surgery, iris color, severity of MGP, number of
      EOM under tension, and type of mechanical stimulation of eye. Type of mechanical stimulation
      of eye or number of EOM under tension increased risk of developing OCR by 0.81 (95% CI,
      0.66-0.98) and 1.29 (95% CI; 1.12-1.63) respectively.

      Conclusions: Induction of anesthesia with ketamine is associated with least hemodynamic
      changes induced by OCR during strabismus surgery. The prediction of oculocardiac reflex
      propensity remains elusive.
    

Intervention name(s): KETAMINE, PROPOFOL, THIOPENTAL
Intervention type(s): Drug
Intervention MeSH terms: Ketamine; Thiopental; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: oculocardiac reflex; strabismus surgery;
Safety and Performance of Electrodes Implanted in the Left Ventricle
Condition: Heart Failure; Ventricular Dysfunction; Cardiomyopathies; Heart Diseases; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases; Cardiomyopathies; Ventricular Dysfunction
Study type: Interventional

Summary: 
      The study is intended to demonstrate the safe implant of small receiver-electrodes into the
      endocardial surface of the left ventricle and to demonstrate its utility in providing cardiac
      resynchronization therapy in heart failure patients.
    

Detailed description: 
      Eligible patients will undergo an acoustic window assessment using transthoracic
      echocardiography. Patients with adequate acoustic windows will undergo implantation of the
      WiCS-LV system.

      Patients will undergo evaluations pre-hospital discharge, and at one month, 3 months, and 6
      months post implantation. Extended follow-up will be obtained via a registry at 1, 2, 3, 4,
      and 5 years post implantation.
    

Intervention name(s): WiCS-LV system
Intervention type(s): Device
Intervention description(s): Wireless cardiac stimulator implant to pace the left ventricle for CRT Transvascular endocardial implantation of wireless pacing Electrode and subcutaneous implantation of Implantable Pulse Generator
Other intervention name(s): Implant
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cardiac Resynchronization Therapy; cardiac pacing; electrical stimulation; bi-ventricular pacing
Small Bowel Capsule Endoscopy Findings in Patients Receiving Cellcept®
Condition: Gastrointestinal Lesions; Signs and Symptoms, Digestive
MeSH terms: Signs and Symptoms, Digestive
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to learn more about symptoms and gastrointestinal lesions
      associated with taking myfortic® by switching patients to a delayed release formulation that
      is developed to alleviate GI symptoms. A comparison of the frequency and severity of GI
      symptoms observed in patients treated with MMF (cellcept®) after conversion to myfortic® will
      be measured by using a self-assessed questionnaire called Gastrointestinal Symptom Rating
      Scale (GSRS). To prove the incidence and improvement of GI lesions in patients treated with
      MMF (cellcept®) after conversion to myfortic® will be measured by using Small Bowel Capsule
      Endoscopy (SBCE).
    

Detailed description: 
      Myfortic® recently introduced to the market has shown to be similar to MMF in how effectively
      it works and how well it is tolerated. Both drugs have the same active ingredient, but they
      are different in the way that they deliver them to the body. Myfortic® is an advanced,
      enteric coated formulation of mycophenolate sodium (EC-MPS) that delays the release of the
      active ingredient, MPA. MPA has more potent effects on the lymphocytes than other cells. This
      makes for improved GI tolerability of the MPA therapy.
    

Intervention name(s): Small bowel capsule endoscopy (SBCE); myfortic
Intervention type(s): Procedure; Drug
Intervention description(s): SBCE will be performed at Day 2 and Day 30.; switching from mycophenolate mofetil to mycophenolic acid on equimolar basis
Other intervention name(s): PillCamEso; EC-MPS
Intervention MeSH terms: Mycophenolic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal transplant recipients; Gastrointestinal findings in small bowel capsule endoscopy; Mycophenolic acid; Mycophenolate Mofetil; Mycophenolate Sodium
Improvement of Humoral Immune Response With Hemodialysis on BK-F Membrane: Correlation to Soluble CD40 Clearing
Condition: Chronic Renal Failure; Humoral Immune Alterations
MeSH terms: Kidney Failure, Chronic
Study type: Interventional

Summary: 
      The aim of this study is to improve the humoral immune response efficiency of hemodialyzed
      patient by the use of PMMA membrane (BK-F) able to clear the soluble form of CD40 in a model
      of anti-HBV vaccination
    

Detailed description: 
      Chronic renal failure is associated with humoral immune alterations characterized by a
      diminished vaccine response notably against hepatitis B virus (HBV). Defects in cellular
      contact between immunological cells have been hypothesized to explain this observation but
      the precise mechanism leading to this "immunocompromised" status is not clear. The soluble
      form of CD40 (sCD40) is dramatically increased in the serum of uremic patients, particularly
      in the hemodialyzed patients. This molecule acts like an inhibitor of the CD40/CD154 contact,
      which is pivotal in the establishment of a proper humoral immune response. It has been shown
      that the most elevated sCD40 levels are associated with a lack of response to HBV vaccination
      in the hemodialyzed patients. The majority of the hemodialysis membranes, including high flux
      polysulfone membranes are unable to clear sCD40 from the sera. However, we found that the
      high flux polymethylmetacrylate (PMMA) membrane (BK-F Toray Medical Company, Japan) allows
      for sCD40 clearing.

      The aim of this study is to assess the effect of dialysis on PMMA membrane on the improvement
      of humoral immune response through the efficiency of HBV vaccination in hemodialysed patients
      who were non responders to one ore more previous vaccination and its link to sCD40 clearing.
    

Intervention name(s): High flux polymethylmetacrylate membrane; Polysulfone membrane; Hepatitis B serological control; Seric sCD40 level
Intervention type(s): Procedure; Procedure; Biological; Biological
Intervention description(s): Patients will be hemodialysed with high flux polymethylmetacrylate membranes; Patients be hemodialysed with polysulfone membranes; It will be assessed at week 16, week 20 and week 40; Ir will be measured at inclusion and week 12 by ELISA test according to the manufacturer instructions.
Intervention MeSH terms: Polymethyl Methacrylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Safety and Tolerability of AZD7442 in Healthy Chinese Adults
Condition: Coronavirus Disease 2019 (COVID-19); Healthy Volunteer
MeSH terms: COVID-19; Coronavirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and
      immunogenicity of AZD7442 in Healthy Chinese Adults. vs. placebo
    

Detailed description: 
      A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability,
      Pharmacokinetics, and Pharmacodynamics of AZD7442 in healthy Chinese participants 18 to 55
      years of age, approximately 60 participants will be randomised in a 4:1 ratio to either
      AZD7442 or placebo, administered by intramuscular (IM) injection or intravenous (IV)
      infusion, and approximately 479 days in duration for each participant.
    

Intervention name(s): AZD7442 IM; Placebo IM; AZD7442 IM; Placebo IM; AZD7442 IV; Placebo IV; AZD7442 IV; Placebo IV
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): In cohort 1, participants will be randomized to receive 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) administered sequentially as direct gluteal IM injections.; In cohort 1, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort administered sequentially as direct gluteal IM injections.; In cohort 2, participants will be randomized to receive 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) administered sequentially as direct gluteal IM injections.; In cohort 2, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort administered sequentially as direct gluteal IM injections.; In cohort 3, participants will be randomized to receive 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) mixed in IV bag co-administered as a single IV infusion.; In cohort 3, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort as a single IV infusion.; In cohort 4, participants will be randomized to receive 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) mixed in IV bag co-administered as a single IV infusion.; In cohort 4, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort as a single IV infusion.
Other intervention name(s): AZD7442; Placebo; AZD7442; Placebo; AZD7442; Placebo; Evusheld; Placebo
Intervention MeSH terms: Cilgavimab and tixagevimab drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Coronavirus; COVID-19; AZD7442; Evusheld; LAAB; tixagevimab; AZD8895; cilgavimab; AZD1061
LHA510 Proof-of-Concept Study as a Maintenance Therapy for Patients With Wet Age-Related Macular Degeneration
Condition: Exudative Age-Related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of 84 successive days of topically
      administered LHA510 compared to vehicle in reducing the number of patients requiring
      intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) therapy (Lucentis®) for
      recurrence of active choroidal neovascularization (CNV).
    

Detailed description: 
      On Day -1, patients will receive an IVT Lucentis® injection in the study eye, and then will
      be randomized to receive either topical LHA510 ophthalmic suspension or vehicle in a 1:1
      ratio for 84 days. Patients with recurrence of active CNV in the study eye during the study
      will receive rescue IVT Lucentis® injections. Following the treatment period, subjects will
      return for a follow-up visit and a disposition visit. Only one eye (designated as the study
      eye) will be dosed with either topical LHA510 or vehicle per patient.
    

Intervention name(s): LHA510 ophthalmic suspension; LHA510 vehicle; Ranibizumab ophthalmic solution
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Inactive ingredients used as a placebo comparator; For intravitreal (IVT) injection
Other intervention name(s): Lucentis®
Intervention MeSH terms: Ranibizumab; Ophthalmic Solutions; Acrizanib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: LHA510; PoC; Age-related macular degeneration
A Study of NKTR-358 (LY3471851) in Participants With Systemic Lupus Erythematosus (SLE)
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety and tolerability of a study drug
      known as LY3471851 in participants with SLE. The study will last about 79 days for each
      participant.
    

Detailed description: 
      LY3471851 is a potential first-in-class therapeutic that may address an underlying immune
      system imbalance in people with many autoimmune conditions. It targets the interleukin (IL-2)
      receptor complex in the body in order to stimulate proliferation of inhibitory immune cells
      known as regulatory T cells. By activating these cells, LY3471851 may act to bring the immune
      system back into balance.

      This study will evaluate the safety, tolerability, pharmacokinetics (PK), and immunologic
      effects of multiple doses of LY3471851 in participants with minimal to moderate SLE. The
      effects on SLE disease activity will also be evaluated. SLE participants will be randomized
      to receive multiple subcutaneous (SC) doses of LY3471851 or receive placebo. After receiving
      the last dose of LY3471851 or placebo, participants will be followed for an additional 50
      days to evaluate safety, PK, pharmacodynamics (PD), and preliminary efficacy.
    

Intervention name(s): LY3471851; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): LY3471851 drug product is a sterile liquid for subcutaneous injection that will be diluted with sterile 0.9% sodium chloride solution for injection (USP) prior to administration.; The placebo dosing solution is 0.9% sodium chloride for injection (USP).
Other intervention name(s): NKTR-358
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: T regulatory cells
Evaluation of the Effect of Endoscopic Urethral Procedures Applied After Radical Prostatectomy on Urinary Incontinence
Condition: Prostate Cancer; Incontinence
MeSH terms: Prostatic Neoplasms; Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      The researchers investigated whether endoscopic retrograde urethral interventions applied for
      various reasons after radical prostatectomy (RP) operation cause a change in urinary
      incontinence (UI) level, and if there is a change, whether it changes according to the
      endoscopic procedure time and the endoscopic instrument used.
    

Detailed description: 
      Localized prostate cancer is usually treated with RP. The most common complications after RP
      are erectile dysfunction (ED) and UI. After RP, some patients may require retrograde
      endoscopic urethral intervention. In this study, researchers investigated whether there is a
      change in the UI level in patients that underwent retrograde urethral intervention after RP
      and whether this change was affected by the duration of the procedure and type of endoscopic
      device used.

      Methods: Eighteen patients were included in the study. The patients were divided into 3
      groups based on the endoscopic device used: group 1 rigid cystoscopy, group 2 flexible
      cystoscopy, and group 3 semi-rigid ureterorenoscopy (URS). The Turkish version of the
      International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
      (ICIQ-SF) and the number of pads used daily was questioned before the endoscopic procedure
      and 1 month after the procedure.
    

Intervention name(s): endoscopic surgical intervention
Intervention type(s): Procedure
Intervention description(s): The researchers investigated whether endoscopic surgical procedures performed due to various indications (hematuria, urinary tract stone, suspected bladder mass) in the patient group who had undergone radical prostatectomy, caused a change in urinary incontinence level. The researchers divided the endoscopic instruments used into 3 groups and evaluated whether there was a difference in urinary incontinence level between rigid cystoscope, flexible cystoscope and ureterorenoscope groups.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prostate Cancer; Urinary Incontinence; Endoscopic Surgical Procedures
The Impact of Fruit Juice, Fruit Juice With Pomace, or Whole Fruit on Glycemic Response
Condition: Glycemic Response
Study type: Interventional

Summary: 
      The primary aim of this clinical trial is to compare the effects of a whole orange, orange
      juice alone, and orange juice with pomace, and a whole apple, apple juice alone, apple juice
      with pomace on glycemic response. Fruit pomace is a fiber-rich byproduct that is isolated
      during normal juice production of fruits, such as orange and apple.
    

Detailed description: 
      Study products are matched on total sugar and fiber. Phase I consists of 3 orange study
      products and Phase II consists of 3 apple study products. Subjects consume one fruit test
      portion or beverage test portion per visit day with at least a 3 day washout in between.

      24 hr diet records are reviewed each test day to verify food and drink consistency and a diet
      containing at least 150 g of carbohydrate. Subjects arrive fasted (10-14 h, water only), are
      asked to maintain adequate hydration; and refrain from vigorous physical activity (24 h),
      alcohol consumption (24 h), and tobacco products (for at least 1 h).
    

Intervention name(s): Whole oranges; Whole Apples; Orange juice + orange pomace; Apple juice + apple pomace; Orange juice; Apple juice
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Navel oranges (227 g total); Red Delicious apple with skin (230 g); Orange Juice (149 g) + orange pomace (100g) [40% pomace by weight]; Apple Juice (129 g) + apple pomace (106 g) [45% pomace by weight]; Orange Juice (250 g); Apple Juice (235 g)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Conducted in 2 separate phases (1 phase/fruit) with 3 visits/phase
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: fiber; fruit; pomace; postprandial glycemia