bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Mild Vascular Cognitive Impairment With Yangxue Qingnao Pill
Condition: Cerebrovascular Diseases
MeSH terms: Cerebrovascular Disorders; Cognitive Dysfunction
Study type: Interventional

Summary: 
      In this study, the effectiveness of vascular cognitive impairment was compared among the
      three groups, namely, the xidezhen group, the Yangxue Qingnao pill group and the placebo
      group
    

Detailed description: 
      The risk factors of various cerebrovascular diseases (atherosclerosis, stroke, hypertension,
      coronary heart disease, atrial fibrillation, dyslipidemia, diabetes mellitus) are both risk
      factors of Alzheimer's disease and one of the many causes of vascular dementia. There are
      many manifestations of mental retardation caused by cerebrovascular diseases. The most
      prominent aspect is cognitive and behavioral impairment, which is characterized by mental
      retardation, forgetfulness, misunderstanding and poor calculation ability. Yangxue Qingnao
      pill (z20063808:) is produced by Tianshili Pharmaceutical Group Co., Ltd, And then improve
      the ability of learning and memory. Some clinical application results show that the drug can
      significantly improve the cognitive and behavioral ability of patients with ischemic stroke,
      improve the cognitive function of patients with mild Alzheimer's disease, and improve the
      quality of life. Therefore, this study mainly compared the effectiveness of treatment of
      vascular cognitive impairment in three groups, namely, the xidezhen group, the
      yangxueqingnaowan group and the placebo group.
    

Intervention name(s): Yangxue Qingnao pill; Hydergotoxine mesylate tablets; blank control group
Intervention type(s): Drug; Drug; Other
Intervention description(s): The treatment group (20 cases) was treated with Yangxue Qingnao pill (2.5g / time, 3 times / day, orally for 6 months; The control group (n = 20) was treated with hidezhen 3 mg per day before meals for 6 months; There were 20 cases in the blank control group.Outpatient consultation at any time was prescribed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: cognitive disorder
Effect of Medical Marijuana on Neurocognition and Escalation of Use
Condition: Pain; Insomnia; Depression; Anxiety
MeSH terms: Sleep Initiation and Maintenance Disorders; Marijuana Abuse; Depression
Study type: Interventional

Summary: 
      This study will use a randomized controlled design to test whether patients who use medical
      marijuana, compared to a waitlist control group, experience a change in health outcomes
      (relief of symptoms, or adverse health outcomes such as new-onset symptoms of cannabis use
      disorders, neurocognitive impairments) or brain-based changes.
    

Detailed description: 
      This trial is a randomized, longitudinal study of medical marijuana (MM) that will: (1)
      characterize the impact of MM on indices of addiction, such as CUD, escalation of use,
      tolerance, and withdrawal among those who stop using, (2) assess, via dosing diaries, the
      effect of MM use patterns on use of other medications, and perception of underlying disease
      symptomatology, (3) characterize the impact of MM on neurocognitive performance, including
      executive function, memory, attention, and decision-making and (4) examine evidence for
      impact of MM on brain structure and function. This study will enroll 200 adults with no prior
      history of CUD or heavy marijuana use, who express interest in using MM to treat pain,
      insomnia, anxiety, and/or depression. Participants will be randomly assigned to either an
      active MM arm (n = 100), or to a waitlist control arm (WLC) (n = 100). Participants will be
      assessed at baseline, regularly for 3 months, and at a 6-month and 12-month follow-up for MM
      use behaviors, development of CUD, perception of disease symptomatology, and neurocognitive
      performance. Urine collected at each visit will be assessed with quantitative assays. MRI
      scans will be collected to longitudinally investigate possible brain changes associated with
      MM use.
    

Intervention name(s): Medical Marijuana
Intervention type(s): Drug
Intervention description(s): Patients in this group can choose when, where, and how much medical marijuana to use.
Other intervention name(s): Cannabis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: medical marijuana; cannabis; pain; insomnia; depression; anxiety; addiction; dependence; neurocognition; MRI
MRI Changes of Acute Kidney Injury in COVID-19
Condition: Acute Kidney Injury
MeSH terms: Acute Kidney Injury; Wounds and Injuries
Study type: Observational

Summary: 
      This is a prospective observational cohort study that will aim to recruit 60 participants who
      have had COVID-19, were admitted to hospital, required intensive care, and/or developed AKI
      during their hospital stay. Potential participants will be approached either by telephone by
      a member of the research team or via clinics (nephrology, post-ICU follow up clinics).
    

Detailed description: 
      After the participants have read and understand the Participant Information Sheet, and had
      sufficient time (at least 24 hours) to consider their participation in this study, the
      investigators will ask them to sign a consent form, which shows their willingness to take
      part. The investigators will then collect information from their medical records about their
      hospital admission with COVID-19, including their age, ethnicity, medical conditions, length
      of hospital stay, tablets or any other treatments they received, as well as details of their
      stay in the ICU. The investigators will also arrange their first study visit which should be
      3-6 months after they had been discharged from the hospital. During this first study day, the
      investigators will:

        -  Measure weight and height and take blood pressure.

        -  Take blood and urine samples.

        -  Ask participants to complete three questionnaires about their health, symptoms of
           fatigue and quality of life (SF-36, EQ-5D-5L and Fatigue Questionnaires).

        -  Measure the accumulation of toxins in the skin using a safe, quick (less than five
           minutes) and painless technique called skin autofluorescence. This involves placing the
           forearm on a piece of equipment that shines a light on the skin and measures the amount
           of light that is reflected back.

        -  Conduct an MRI scan of the kidneys, muscles, abdomen and heart. The MRI scan will take
           60-70 minutes in total. The investigators will ask participants not to eat or drink
           anything two hours before the MRI scan.

      After this visit, the investigators will ask participants to come back for two more study
      visits, which will be arranged at 12 and 24 months after their hospital discharge. These
      visits will consist of the same procedures and measurements done in the first study visit.
    

Intervention name(s): MRI scans
Intervention type(s): Procedure
Intervention description(s): This study does not involve any intervention or new treatment. We will conduct MRI scans of the kidneys, muscles, abdomen and heart at baseline, 12 and 24 months after hospital discharge. The MRI scan will take 60-70 minutes in total.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        People who have had COVID-19, were admitted to hospital, required intensive care, and/or
        developed AKI during their hospital stay.
Assessment of Daily Disposable Silicone Hydrogel Lens Wear
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of an investigational silicone hydrogel
      soft contact lens on new contact lens wearers (neophytes) compared to a control of spectacle
      wearers.
    


Intervention name(s): Narafilcon B Contact Lens; Spectacles
Intervention type(s): Device; Device
Intervention description(s): spectacle wearers
Other intervention name(s): Investigational Silicone Hydrogel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Single and Multiple Dose Escalation Study of VX-509 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to evaluate the safety and tolerability of single ascending doses and multiple
      ascending doses of VX-509 administered to healthy male and female subjects
    

Detailed description: 
      Part A of the study will evaluate the safety and tolerability, PK, and PD of single ascending
      doses of VX-509.

      Part B will evaluate the safety and tolerability, PK, and PD of multiple ascending doses of
      VX-509 administered for 14 days.

      A total of 72 subjects will be enrolled: 36 subjects in Part A and 36 subjects in Part B.
    

Intervention name(s): VX-509
Intervention type(s): Drug
Allocation: Randomized
Masking: Double
A Safety Study of NNZ-2566 in Pediatric Rett Syndrome
Condition: Rett Syndrome
MeSH terms: Rett Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether NNZ-2566 is safe and well tolerated in the
      treatment of Rett syndrome in children and adolescents.
    

Detailed description: 
      Rett syndrome is a neurodevelopmental disorder primarily affecting females. The disorder is
      characterized by apparent normal development in early infancy (6-18 months), followed by a
      period of regression with onset of systemic and neurological signs. The CNS symptoms of Rett
      syndrome include learning disability, autism symptomatology and epilepsy and these can be
      severe and highly debilitating. Affected individuals also show signs of autonomic
      dysfunction, reflected in cardiovascular and respiratory abnormalities. There is no currently
      effective treatment for Rett syndrome.

      This study will investigate the safety, tolerability and blood pharmacokinetics of treatment
      with oral administration of NNZ-2566 at 50 mg/kg, 100 mg/kg, 200 mg/kg BID, or placebo BID,
      in children and adolescent females with Rett syndrome. The study also will also investigate
      measures of efficacy and biomarkers during treatment.
    

Intervention name(s): NNZ-2566; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Glycyl-L-2-Methylpropyl-L-Glutamic Acid (NNZ-2566) supplied as a lyophilized powder for reconstitution with strawberry flavored solution 0.5% v/v in Water for Injection.; Strawberry flavored solution and Water for Injection
Other intervention name(s): trofinetide; Strawberry flavoring
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism; Rett's syndrome; Rett disorder; Rett's disorder; Ataxia
An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study was to assess the effect of two doses of teriflunomide, in
      comparison to placebo, on the frequency of multiple sclerosis (MS) relapses in participants
      with relapsing MS.

      Key secondary objective was to assess the effect of the two doses of teriflunomide, in
      comparison to placebo, on disability progression.

      Other secondary objectives were:

        -  To assess the effect of the two doses of teriflunomide in comparison to placebo on:

             -  Fatigue;

             -  Health-related quality of life, a measure of the impact of the participant's health
                on his or her overall well being.

        -  To evaluate the safety and tolerability of teriflunomide.
    

Detailed description: 
      The study consists of:

        -  A core treatment period: Teriflunomide 7 mg or Teriflunomide 14 mg or placebo was
           administered in double-blind fashion until a fixed common end date which was
           approximately 48 weeks after randomization of the last participant.

        -  An extension treatment period: the highest dose of teriflunomide was administered in
           open-label fashion to participants who successfully complete the core treatment period
           and wish to continue.

      The overall treatment period was followed by a 4-week elimination follow-up period.
    

Intervention name(s): Placebo; Teriflunomide
Intervention type(s): Drug; Drug
Intervention description(s): Film-coated tablet
Oral administration; Film-coated tablet
Oral administration
Other intervention name(s): HMR1726
Intervention MeSH terms: Teriflunomide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: relapsing multiple sclerosis
ToothWave Plaque and Gingivitis Study
Condition: Gingivitis; Plaque; Calculus, Dental
MeSH terms: Gingivitis; Dental Calculus; Calculi
Study type: Interventional

Summary: 
      The objective of the study is to evaluate the safety and efficacy of the home-use device
      Silk'n toothbrush (ToothWave) for the improvement in dental health through the reduction of
      plaque, gingivitis, and calculus.
    

Detailed description: 
      This is a single blind, prospective study aimed to evaluate the safety and efficacy of the
      Silk'n toothbrush in reduction of gingivitis, dental plaque and calculus.

      The study includes 84 treatment sessions, twice a day, and 4 clinic visits over a period of 6
      weeks.

      One treatment group (Silk'n toothbrush - ToothWave) and 1 control group (an ADA approved
      power toothbrush (PTB)) will participate in the study.

      For each patient, assessment data will be collected at baseline, 4 weeks, and at 6 weeks. The
      average data sets will be calculated for each group.

      Treatment is defined as a timed 2 minutes of teeth brushing in a regular man-ner, twice a day
      (morning and evening). Brushing will be undertaken using the Silk'n toothbrush and standard
      fluoride toothpaste. The control group will use a regular PTB and standard fluoride
      toothpaste.
    

Intervention name(s): RF utilizing powered toothbrush; Control placebo with no RF
Intervention type(s): Device; Device
Intervention description(s): RF utilizing Powered toothbrush; Placebo control, with no RF
Other intervention name(s): RF toothbrush
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single blind prospective study
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of Glucosanol™ in Body Weight Reduction
Condition: Overweight and Obesity
MeSH terms: Overweight; Body Weight
Study type: Interventional

Summary: 
      It was proven in a previous clinical study that Glucosanol™ is effective and safe in reducing
      weight in the overweight and obese. The present study aims at expanding the data concerning
      the weight management effect of Glucosanol™ in overweight and moderately obese population.
    


Intervention name(s): Glucosanol 350mg; Glucosanol 500mg; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
ERAS for Pediatric Acute Appendicitis
Condition: Pediatric Disorder; Complicated Appendicitis
MeSH terms: Appendicitis
Study type: Interventional

Summary: 
      This multicenter, prospective randomized controlled study is designed to applicate
      perioperative Enhanced recovery after surgery (ERAS) management for children with acute
      complicated appendicitis, the aim is to promote postoperative recovery, shorten the hospital
      length of stay, and reduce the incidence of postoperative complications.
    

Detailed description: 
      The purpose of this study is through multi-center prospective RCT research, to discuss the
      application of ERAS in children with acute complicated appendicitis, including its
      preoperative rehydration, postoperative analgesia, preoperative and postoperative antibiotics
      application, as well as the discharge standards and so on. The major outcome is whether it
      can reduce the length of stay in hospital (LOS), secondary outcomes are included the
      incidence of postoperative complications and postoperative readmission rate, etc.
    

Intervention name(s): ERAS
Intervention type(s): Combination Product
Intervention description(s): preoperative pain control;
avoiding application of ureter;
avoiding application of gastric tube;
avoiding application of irrigation;
avoiding application of drainage;
early exercising postoperatively;
early oral feeding postoperatively;
early discharging.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ERAS; Pediatric surgery; Emergency; Both of systolic and diastolic will be measured
Impact of Maternal Xylitol Consumption on Mutans Sterptococci
Condition: Dental Caries and Streptococcus Mutans Count
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 4

Summary: 
      The study was designed to determine whether maternal xylitol consumption through regular
      chewing of xylitol gums can affect the salivary mutans streptococci (MS), dental caries, and
      dental plaque levels of their children.
    

Detailed description: 
      Method: Study sample included 60 mother and child pairs with high salivary mutans
      streptococcus (MS) levels. Samples were randomly divided into experimental group (30 pairs)
      and control group (30 pairs). Mothers in the experimental group received xylitol chewing gum
      treatment three times/day for three months, whereas the controls received fluoride varnish.
      Both groups received oral hygiene instructions, dietary counseling and restorative treatment.
      All children were examined after 6, 12 and 18 months from the initiation of the study to
      assess caries, plaque and salivary mutans streptococcus (MS) levels.
    

Intervention name(s): xylitol; fluoride varnish application
Intervention type(s): Drug; Drug
Intervention description(s): Mothers in the experimental group were instructed to chew 1 pellet of xylitol gum (Fennobon Oy, Yrittäjäntie, Finneland -gum, 3 times ) for a period of 3 months. control mothers did not receive any medications. All mothers received oral hygiene instructions and restorative treatment when needed. Offspring of both the experimental and control groups did not receive any medication and were followed for at 6,12, 18 and 24 month from initiation of mothers consumption. month; The control group participated in a preventive program under the supervision of the Pediatric Dentistry Department. The program activities consisted of oral hygiene instructions, fluoride varnish application (Duraphat 5% Na F ,Ultradent Products, Utah, USA) and restorative treatment when needed.
Other intervention name(s): Fennobon Oy, Yrittäjäntie, Finneland - chewing; gum, tablet , 1.8g and containing 66% xylitol by weight,; fluoride varnish (Duraphat 5% Na F ,Ultradent Products, Utah, USA)
Intervention MeSH terms: Fluorides; Fluorides, Topical
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Xylitol; prevention; Mutans streptococci; caries; plaque; children
The Use of Psychomotor Vigilance Testing in the Assessment of Pediatric Obstructive Sleep Apnea
Condition: Pediatric Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Obstructive sleep apnea results in decreased attentiveness and response times in patients.
      The objective of this study is to quantify these consequences in pediatric OSA patients using
      an already established tool for examining the results of sleep deprivation and fragmentation:
      psychomotor vigilance testing. PVT has been used in children, but has not been studied in
      pediatric OSA patients. This study aims to employ PVT along the normal course of diagnosis
      and treatment of pediatric OSA patients in our clinical practice at Arkansas Children's
      Hospital. The investigators hypothesize that pediatric OSA patients will exhibit decreased
      PVT scoring when compared to children without OSA, and that PVT can be used to diagnose and
      monitor treatment outcomes in these patients.
    


Intervention name(s): Psychomotor Vigilance Testing
Intervention type(s): Device
Intervention description(s): The purpose of this study is to examine the use of psychomotor vigilance testing (PVT) as a tool in the diagnosis and prediction of pediatric obstructive sleep apnea. PVT simply involves responding to a light by pressing a button on a small handheld device. It is a simple measure of reaction time.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Obstructive Sleep Apnea; Pediatric Obstructive Sleep Apnea; OSA; PVT; Psychomotor Vigilance Testing; Psychomotor Vigilance Task