bioihbjkbjnl/mcl2 huggingface dataset:
The Evaluation of a School Climate Videogame Intervention
Condition: Cognitive Reappraisal; Self Efficacy
Study type: Interventional

Summary: 
      A randomized control trial of a videogame intervention to assess and improve school climate.
    

Detailed description: 
      To assess the acceptability and preliminary efficacy of a videogame intervention designed to
      teach teens the skills in restructuring thoughts and then empowering them to take action and
      improve their school climate.

      For this project, the play2PREVENT Lab aims to assess the acceptability and preliminary
      efficacy of a videogame intervention designed to teach teens the skills in restructuring
      thoughts and then empowering them to take action and improve their school climate. Program
      and school staff will enroll participants between the ages of 14-19 years old to play our
      videogame during their after school programs. Before and after gameplay, participants will
      answer assessment questions related to self-efficacy, cognitive reappraisal, and dimensions
      of school climate. Questions will also assess participants' feedback on the videogame.
      Students not randomly assigned to the videogame intervention will only respond to assessment
      questions. The data will be transmitted electronically via Qualtrics data collection platform
      to the Lab for further analysis.
    

Intervention name(s): videogame; School Climate Assessment Survey
Intervention type(s): Device; Behavioral
Intervention description(s): A videogame intervention that is interactive and engaging that teaches adolescents how to restructure negative automatic thoughts through an adapted thought record (a technique used in cognitive behavioral therapy to improve moods) by modeling how to do so and then empower them through real-life activities to improve their school climate. The videogame intervention is comprised of five mini-games, each containing a short narrative that models how to restructure negative automatic thoughts and navigate through challenging situations that often take place in school settings. The topics of each mini-game are informed by the constructs of school climate according to the National School Climate Center. Students using the videogame intervention will be prompted to think deeply and reflect on the narratives presented in each mini-game.; A school climate assessment survey will include items adapted from questions developed by the National School Climate Center. Items will assess various dimensions of school climate including safety, social media, relationships, support for learning, and environment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
A Double-Blind Trial of Adjunctive Valacyclovir to Improve Cognition in Early Phase Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary aim of the study is to determine the efficacy of adjunctive valacyclovir, in
      comparison to placebo, to improve visual (Brief Visuospatial Memory Test) and working
      (composite score of the Spatial Span and Letter Number Span tests) memory in individuals who
      are HSV-1 positive and early in the course of schizophrenia.

      We hypothesize that individuals who are HSV-1 positive, but not those who are HSV-1 negative,
      will demonstrate significant valacyclovir efficacy for visual and working memory.
    

Detailed description: 
      One hundred and seventy-five participants (N=70 HSV-1 seropositive and N=105 HSV-1
      seronegative) will be randomized 1:1 to receive adjunctive valacyclovir or adjunctive placebo
      for a 16 week period. The primary outcome that will be assessed is improvement in changes in
      visual and working memory scores in HSV-1 positive and negative participants over the course
      of the study. We will also measure the overall cognitive functioning and the severity of
      psychiatric symptoms over the course of the study and will evaluate the tolerability and
      safety of valacyclovir treatment in this population. In addition, we will explore the
      relationship between changes in the levels of inflammatory markers (HSV2, CMV, EBV, CRP, and
      Toxoplasmosis) and treatment response over the course of the study.
    

Intervention name(s): Valacyclovir HCI 500 mg tablets; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Valacyclovir HCI 500 mg capsules 6/day oral for 16 weeks; placebo capsules 6/day oral for 16 weeks
Other intervention name(s): placebo capsules
Intervention MeSH terms: Valacyclovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: schizophrenia; schizoaffective; schizophreniform; inflammatory markers; HSV1; cognition; early psychosis; valacyclovir
A Double-blind, Randomized, Parallel Design Study to Compare the Effectiveness of Sugammadex Versus Neostigmine in Improving Surgical Condition in Subjects Undergoing Laryngeal Microsurgery
Condition: General Anesthesia
Study type: Interventional

Summary: 
      Investigators hypothesized that the surgical condition will be improved with the use of
      sugammadex in patients undergoing laryngeal microsurgery. Investigators will compare the
      effect of sugammadex and neostigmine on the surgical condition during laryngeal microsurgery.
    


Intervention name(s): Sugammadex; Neostigmine
Intervention type(s): Drug; Drug
Intervention description(s): In sugammadex group, sugammadex (Bridion, Merck Shart and Dohme (MSD), Oss, the Netherlands) will be administered intravenously in different doses according to the degree of muscle relaxation. Sugammadex 8 mg/kg will be administered if there is no response on post-tetanic count (PTC) stimulus. Sugammadex 4 mg/kg will be administered if PTC is more than 1 or 2. Sugammadex 2 mg/kg will be administered if T2 response appears on train-of-four (TOF) stimulus.; In neostigmine group, neostigmine 50 ㎍/kg will be administered intravenously with glycopyrrolate 10 ㎍/kg when the T2 response appears on TOF stimuli.
Intervention MeSH terms: Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sugammadex; Neostigmine; Surgery
A Trial That Compound Clobetasol Propionate Ointment Treats Patients With Mild to Moderate Psoriasis Vulgaris.
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 4

Summary: 
      A multi-center, randomized, single blind, positive controlled trials that assess the
      effectiveness, safety and cost-effectiveness analysis in patients with mild to moderate
      psoriasis vulgaris and compare Compound Clobetasol Propionate Ointment to Calcipotriol
      Betamethasone Ointment.

      Objectives of Study：

        1. Compare Compound Clobetasol Propionate Ointment to Calcipotriol Betamethasone Ointment
           in the treatment of mild to moderate psoriasis vulgaris in effectiveness and safety;

        2. Compare the cost-effectiveness analysis of two treatment programs.
    


Intervention name(s): Compound Clobetasol Propionate Ointment; Calcipotriol Betamethasone Ointment
Intervention type(s): Drug; Drug
Intervention MeSH terms: Betamethasone; Clobetasol; Calcipotriene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Interaction of Cocoa Methylxanthines With Cocoa Flavanol Related Vascular Effects
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Epidemiological studies suggest that certain foods rich in flavanols, including cocoa
      products, red wine, and tea, are associated with decreased cardiovascular mortality and
      morbidity. Dietary interventional studies have corroborated this finding and showed that
      flavanols can acutely and after sustained ingestion improve surrogate markers of
      cardiovascular risk including endothelial function. Endothelial dysfunction is the key event
      in the development and progression of cardiovascular disease. Aging is the major
      non-modifiable cardiovascular risk factor associated with progressive decline in endothelial
      function, vascular stiffening and increase in blood pressure.

      However, in addition to flavanols, other potentially bioactive compounds are present in
      cocoa, in particular methylxanthines. Little is known about the vascular effects of cocoa
      methylxanthines, i.e. mainly theobromine, in particular when consumed together with flavanols
      in cocoa products. The aim of the study is to characterize the nutrient-nutrient interaction
      between cocoa flavanols and cocoa methylxanthines.
    


Intervention name(s): flavanol; methylxanthine; flavanol + methylxanthine
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: flavanols; cardiovascular effects; nutrition-nutrition interaction
Safety and Effectiveness of the MED-EL Electric-Acoustic System
Condition: Hearing Loss
MeSH terms: Hearing Loss; Deafness
Study type: Interventional

Summary: 
      The purpose of this investigation is to demonstrate the safety and effectiveness of the
      MED-EL Electric-Acoustic System (EAS), a medical device that combines the use of a cochlear
      implant with an external electric-acoustic processor designed to provide benefit in speech
      perception and sound quality to individuals with a sensorineural hearing loss with minimal
      changes in residual hearing. The acoustic component of the processor will aid residual
      acoustic hearing in low frequency ranges, while the cochlear implant and electric component
      of the processor will be used to electrically stimulate the auditory nerve across a wide
      range of frequencies necessary for speech perception.
    


Intervention name(s): Electric Acoustic System
Intervention type(s): Device
Intervention description(s): Combination of a cochlear implant and a hearing aid
Other intervention name(s): EAS; Electric Acoustic Systems
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sensorineural hearing loss; ski slope audiogram; electric acoustic stimulation
A Trial of SHR6390 in Healthy Caucasian Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single center, single dose, open-label clinical study to evaluate the
      pharmacokinetics, safety and tolerability of SHR6390 under fasting conditions in healthy
      caucasian volunteers
    

Detailed description: 
      The objective of this study is to determine the comparative pharmacokinetics, safety and
      tolerability of single oral dose of reformulated SHR6390 in healthy volunteers under fasting
      conditions.

      Each subject will receive a single dose of SHR6390, blood samples will be collected before
      dosing and at various time points up to 144 hours after drug administration, safety and the
      statistical analysis of the pharmacokinetic data will be obtained from this study
    

Intervention name(s): SHR6390
Intervention type(s): Drug
Intervention description(s): a selective small-molecule CDK4/6 inhibitor
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A total of 36 healthy volunteer subjects will be enrolled in this study. 12 subjects subjects will take a single dose of SHR6390 in each of the 3 dose cohorts
Masking: None (Open Label)
Primary purpose: Other
Continuous Glucose Monitoring in Type 2 Diabetes Mellitus
Condition: Diabetic Vascular Complications
MeSH terms: Diabetic Angiopathies
Study type: Observational

Summary: 
      It is well known that lowering average blood glucose decreases the risk of diabetic
      complications involving the small vessels, such as those found in the eyes, nerves and
      kidney. It is less clear however, if controlling fluctuations in blood glucose will further
      help to prevent such complications.

      The purpose of this study is to examine the relationship between extreme fluctuations in
      glucose and damage to the blood vessel lining.
    

Detailed description: 
      Studies have shown that glycemic variability is associated with oxidative stress which in
      turn has been correlated with endothelial damage. Further, endothelial damage has been
      identified as a critical event lending way to the vascular complications seen in many disease
      states.

      The specific aim of this study is to investigate the relationship between short-term glycemic
      variability and biomarkers of endothelial dysfunction while analyzing the influence of
      different variables and adjusting for covariates.

      Data obtained from a continuous glucose monitoring system(CGMS), a device that continuously
      records interstitial glucose for a 72 hour period, is used to calculate glycemic variability.
      Serology for the determination of endothelial dysfunction biomarkers is obtained on day
      three.

      Pearson and Spearman Rank Order correlations are utilized to determine whether there are any
      significant correlations between measures of glycemic variability and biomarker levels of
      endothelial dysfunction. Multiple regression analysis would also determine if glycemic
      variability predicts elevated biomarker levels even after controlling for other variables.

      Provided the high prevalence of diabetic complications and their staggering socioeconomic
      costs, it is important to elucidate the relationship between glycemic variability and
      endothelial dysfunction.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult subjects with Type 2 Diabetes Mellitus from an outpatient Endocrinology Practice
      
Biospecimen description: 
      Serum samples
    
Keywords: Glycemic Variability; Endothelial Dysfunction
From Molecules to Cognition: Inhibitory Mechanisms in ASD and NF1
Condition: Autism Spectrum Disorder; Neurofibromatosis 1
MeSH terms: Neurofibromatoses; Neurofibromatosis 1; Neurofibroma; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      This study aims to investigate synaptic physiology and behavioral inhibition in patients with
      NF1 and ASD and to answer whether inhibitory deficits at these levels are modulated by
      lovastatin.

      Structure: (1) Visit 1: Baseline assessment- participant's characterization, baseline outcome
      measures and additional evaluations, (2) 3 consecutive days of physiologically probing
      drug/placebo intake, (3) Visit 2: Outcome measures and additional evaluations in the day
      after the last drug/placebo intake, (4) Washout period of 4 to 6 weeks, (5) 3 consecutive
      days of drug/placebo intake, (6) Visit 3: Outcome measures and additional evaluations in the
      day after the last placebo/drug intake.
    

Detailed description: 
      The literature has shown synaptic inhibitory dysfunction in both ASD and NF1. Here the
      investigators aim to test whether a mechanistic link can be established between that synaptic
      inhibitory dysfunction, systems levels changes in oscillatory synchrony and regulation of
      inhibition and treatment with Lovastatin in these two neurodevelopmental disorders. The
      investigators will explore this link through the application of complementary quantitative
      measures (putative biomarkers), such as magnetic resonance spectroscopy (MRS) transcranial
      magnetic stimulation (TMS) and electroencephalogram (EEG) applied to the same group of adult
      patients before and after the lovastatin or placebo intake during three days.

      The intervention comprehends three sessions: the first two visits will occur in the same week
      and the third visit will take place 4 to 6 weeks later. In the first visit (baseline
      assessment), participants will perform neuropsychological, EEG, MRS and TMS assessment. In
      the other two visits participants will repeat EEG, MRS and TMS assessments to study possible
      post- intervention effects. Participants will intake 60mg of Lovastatin or Placebo during
      three consecutive days before the second and the third visits.
    

Intervention name(s): Lovastatin 60 MG; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): 60 MG Lovastatin per day for 3 consecutive days; 60 MG Placebo per day for 3 consecutive days
Intervention MeSH terms: Lovastatin; L 647318; Dihydromevinolin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Inhibition; GABA; molecular imaging; functional magnetic resonance imaging; Autism Spectrum Disorder; Neurofibromatosis 1
Rigid Thoracoscopy Versus CT-Guided Pleural Needle Biopsy
Condition: Pleural Effusion; Pleural Diseases
MeSH terms: Pleural Effusion; Pleural Diseases
Study type: Interventional

Summary: 
      The aim of this study is to compare the rigid thoracoscopy with CT-guided pleural needle
      biopsy by the diagnostic efficacy and safety in patients with pleural effusion.
    

Detailed description: 
      Pleural needle biopsy with Abrams needle, which can be performed by all chest physicians, is
      a simple, safe and cheap method of obtaining tissue from pleura, but its diagnostic rate is
      between 7 % -72 %, ~ 50 %. Problems for Abrams needle are scattered tumoral involvement on
      pleura, blind performance, small tissue sampling, to tend to early and dense fibrosis and
      usually involvement of lower pleural surface and diaphragmatic pleura.

      Pleural needle biopsy with Abrams' needle, which can be performed by all chest physicians, if
      done with image guided and if this increase the diagnosis rate, the number of second
      procedure which is more expensive and hard will decrease.

      The study aims the comparison of rigid thoracoscopy with CT-guided pleural needle biopsy by
      the diagnostic efficacy and safety in patients with pleural effusion.

      It has been planned that a total of 120 patients accepted to the study who have pleural
      effusion at plain chest roentgenogram. All patients are being randomized after underwent
      contrast-enhanced CT. Undiagnosed patients of biopsy group are performed thoracoscopy and
      undiagnosed patients of thoracoscopy group followed up.

      Two groups will compare by age, sex, Karnofsky performance status (KPS), diagnosis and
      complication rate.
    

Intervention name(s): Ct-guided pleural needle biopsy; Thoracoscopy
Intervention type(s): Procedure; Procedure
Intervention description(s): Biopsy of pleura; Biopsy of pleura
Other intervention name(s): Diagnose; Diagnose
Allocation: Randomized
Primary purpose: Diagnostic
Keywords: Thoracoscopy; Pleural needle biopsy; Malignant pleural diseases; Mesothelioma; Diagnosis; Pleurisy tuberculosis; Patients with pleural diseases and pleural effusion should have been included in the study.
A Randomized, Placebo-Controlled, Double-blind Study of Tianshu Capsule in the Treatment of Migraine.
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the safety and the efficacy of Tianshu capsule
      treating Migraine Headache.
    

Detailed description: 
      Primary headache disorders,particularly migraine is globally prevalent. Many studies show the
      burdens they impose: pain, disability, reduced quality of life (QoL), marked impairment of
      participation in work and social activities, and heavy financial costs.

      The purpose of this study is to evaluate the safety and the efficacy of Tianshu capsule
      treating Migraine Headache. To provide a safe and effective treatment of Migraine Headache.
    

Intervention name(s): Tianshu capsule; Sugar pill
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Migraine; Tianshu capsule
Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics of a Single 3 mg Cytisinicline Dose
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of this study are:

        1. To obtain information on the pharmacokinetics of cytisinicline following a single oral
           dose in subjects with varying degrees of renal impairment relative to matched controls
           with normal renal function.

        2. To investigate the extent of cytisinicline removal by hemodialysis.
    


Intervention name(s): cytisinicline
Intervention type(s): Drug
Intervention description(s): film-coated oral tablets containing 3 mg cytisinicline
Other intervention name(s): cytisine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dialysis
A Clinical Study of the GO-LIF® Approach for Lumbar Spinal Fixation
Condition: Lower Back Pain
MeSH terms: Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to collect data regarding the safety and feasibility of the
      GO-LIF procedure for spinal fixation and stabilization, in conjunction with conventional
      approaches for interbody lumbar fusion. This is in order to allow for evidence-based
      comparison to pedicle-screw-based techniques as described in the literature.
    


Intervention name(s): GO-LIF - Guided Oblique Lumbar Interbody Fusion
Intervention type(s): Procedure
Intervention description(s): All patients will undergo single-level instrumented interbody spinal fusion surgery with instrumentation.
Upon induction of general anesthesia, the patient will be positioned prone on a radiolucent operating table and prepared according to standard hospital procedure. An interbody fusion will be performed according to standard procedure and as indicated by the surgeon. The interbody fusion portion of the surgery will be carried out using any current technique - such as PLIF, TLIF, PLF, PLLF, XLIF or ALIF. The fusion strategy can be performed in an open or minimally invasive manner, as indicated. The interbody device will be inserted after the screws trajectory will be drilled and a 4.5mm Trajectory holder is in place. This will assure the surgeon that no collision will occur between the interbody and the screws.
Upon completion of the fusion stage of the surgery, SpineAssist will be used to introduce the GO-LIF screws for fixation of the spinal levels to be fused.
Other intervention name(s): Mazor; SpineAssist; GO-LIF
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment