bioihbjkbjnl/mcl2 huggingface dataset:
Near Horizontal Heterophoria in Chinese Children
Condition: Myopia, Progressive
MeSH terms: Strabismus; Myopia, Degenerative
Study type: Observational

Summary: 
      This study aimed to assess the association of refraction and axial length with
      near-horizontal heterophoria in a large population-based study of school-aged Chinese
      children. The study makes a significant contribution to better know the etiology of myopia
      progression and ocular axial length development. Further, this study will be of interest to
      the readership of your journal because its noteworthy finding and which could contribute to
      guide recommendations for targeted interventions to slow myopia progression.
    

Detailed description: 
      Myopia is becoming a global public health burden which is believed to have a multifactorial
      etiology. The relationship between heterophoria and refraction remains controversial. We
      describe the association of refraction and axial length (AL) with heterophoria in a large
      population-based study of school-aged Chinese children. Eleven thousand thirteen elementary
      school children grades 1-6, were included in this school-based, cross-sectional study. Near
      phoria data was quantified by using Maddox rod test and prism at 33 cm. Children in each
      grade level were sorted into three groups based upon phoria: 1) those with more than six
      prism diopters (PD) exophoria, 2) those with zero to six PD exophoria, and 3) those with any
      amount of esophoria. Autorefraction was measured by autorefractor (Topcon KR8900, Japan) and
      AL was measured by Optical Biometer AL-Scan (Nidek AL-Scan, Japan). A generalized additive
      model (GAM) was applied with a Gaussian link to explore the association between the
      refractive error or axial length and heterophoria. An additional age-adjusted model was also
      employed for analysis.
    

Intervention name(s): axial length and refractive error
Intervention type(s): Other
Intervention description(s): Comparing the correlation between heterophoria and refraction, even after age adjustment.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 15,081 Chinese children between the ages of 6 and 13 years were enrolled in this
        study. Subjects with eye diseases or strabismus were excluded, so data validated from
        11,013 children were used for analysis.
A Micro/Nano Device for Exhaled Breath Analysis
Condition: Lung Cancer; Pulmonary Disease
MeSH terms: Lung Diseases
Study type: Observational

Summary: 
      Use of a microfabricated silicon device to concentrate ultra trace volatile organic compounds
      (VOCs) in human exhaled breath for quantitative analysis of VOCs.
    

Detailed description: 
      Will use Fourier Transform Mass Spectrometry (FT-MS) and Gas Chromatography-Mass Spectrometry
      (GC-MS) to analyze concentrated VOCs. The purpose of this study is to search for
      disease-related markers in the breath in subjects with known or suspected lung or other
      cancer, or pulmonary disease.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Those fitting inclusionary criteria between 20 and 85 years of age, with or without history
        of pulmonary disease or cancer.
      
Biospecimen description: 
      Breathe samples
    
Keywords: Lung cancer; pulmonary disease
Internet-delivered CBT for Adolescents With GAD
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This multiple baseline evaluation aims to test the feasibility and preliminary effectiveness
      of Internet-delivered cognitive behavioral therapy (ICBT) for adolescents with Generalized
      Anxiety Disorder (GAD).
    

Detailed description: 
      This pilot study aims to test Internet-delivered Cognitive Behavioral Therapy (ICBT) for
      adolescents with Generalized Anxiety Disorder (GAD)

      The study has a single case research design (multiple baseline) and will include 12
      participants with GAD according to a semi structured diagnostic interview.

      Participants will be randomized to either two, six or ten weeks baseline measurements prior
      to starting treatment, and will thus work as their own controls.

      Primary outcome measures will be collected at 10 weeks after treatment start. Follow-up
      assessments will be made three month after treatment.
    

Intervention name(s): Internet-Delivered Cognitive Behavioral Therapy
Intervention type(s): Behavioral
Intervention description(s): Therapist-supported CBT delivered online.
Other intervention name(s): ICBT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GAD; Adolescents; Internet-delivered Cognitive behavioral therapy; ICBT; CBT
A Phase II Clinical Study of Lidocain Pertubation as Treatment for Couples With Unexplained Infertility
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2

Summary: 
      The study tested the hypothesis that a pertubation with a lidocain solution will enhance
      pregnancy rate.
    

Detailed description: 
      In a prospective study, patients were randomized during a clomiphene citrate stimulated cycle
      to either pertubation with low-dose lidocain or no pertubation before insemination.
    

Intervention name(s): Pertubation with Lidocain Solution
Intervention type(s): Drug
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pertubation, tubal flushing, intrauterine insemination.
Motion Sickness on Astrolabe's Vessel
Condition: Sea Sickness
MeSH terms: Motion Sickness
Study type: Observational

Summary: 
      Sea sickness syndrome is present for 80% of persons on board when the boat rotation missions
      Astrolabe, sometimes there is a risk of very significant dehydration. A special unit
      specialized in the fundamental study of the vestibular system (inner ear), sensory organ at
      the base of visual-vestibular conflict inducing this syndrome, also provides medical support
      for parabolic flights (flight reproducing weightlessness) where this syndrome is strongly
      present. The goal of the study is to assess the frequency of occurrence of this sea sickness
      syndrome on the Astrolabe, to understand the triggers (type of boat movements, personality
      traits, anxiety / stress) without changing habits on board for those on board taking a
      antinaupathique treatment given by the ship's doctor. This study will be done in
      collaboration between INSERM U 1075 (France) and the Laboratory of military research VIPER
      specialized in extreme environments (Belgium). The ultimate goal will be to provide the best
      recommendations and the best treatment regimen to alleviate as best as possible the symptoms
      of people on board of the Astrolabe so scientists on board can perform their work.
    

Detailed description: 
      Background: The objectives were to assess the prevalence, severity, medication taken and to
      look for predictive factors, in order to better identify characteristics of passengers at
      risk of motion sickness during transport scientists travelling from Hobart in Tasmania to the
      French polar stations in Antarctica.

      Methods: Two hundred and thirty-nine passengers were surveyed over 4 years with 4 round trips
      per year using Motion Sickness Susceptibility Questionnaire (MSSQ), Simulator Sickness
      Questionnaire (SSQ), state-trait anxiety test (STAI-Trait and STAI-State), and general
      parameters (age, gender, number of trips, jet-lag, direction of the trip), medication,
      calculation of the distance of each passenger's cabin to the Centre of Gravity (CoG.).
    

Intervention name(s): sea sickness questionnaires
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Astrolabe passengers
Low Dose Ketamine for Management of Acute Severe Pain in the Emergency Department
Condition: Pain
MeSH terms: Emergencies
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to address both the management and evaluation of pain. The primary aim of
      this study is to determine the efficacy of low dose ketamine in adults with moderate to
      severe pain in the emergency department as compared with parenteral opioids alone. Another
      aim is to examine the safety of low dose ketamine compared to opioids alone.

      The investigators hypothesize that low dose ketamine will result in more effective pain
      control than morphine alone and will not be associated with an increase in adverse events.
    

Detailed description: 
      Management and assessment of pain in the Emergency Department (ED) can be challenging.
      Treatment of pain is most often accomplished by parenteral opioids analgesics. However,
      inadequate analgesia is often a problem when opioids alone are relied on for pain control. In
      the peri-operative setting ketamine has been used as an adjunct to opioids for acute pain.
      Ketamine may play a role in maximizing analgesia in the ED.
    

Intervention name(s): Ketamine 0.15mg/kg; Ketamine 0.3mg/kg; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): 0.15mg/kg ketamine delivered IV (in the vein) following clinician assessment in ER. Number of cycles: until discharge or 6 hours elapses.; 0.3 mg/kg ketamine delivered IV (in the vein) following clinician assessment in ER. Number of cycles: until discharge or 6 hours elapses.; Placebo injection of 0.9% normal saline of a similar volume (0.05ml/kg)
Other intervention name(s): Ketamine; Ketamine
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Ketamine; Acute pain; Pain control; Pain
Active Immunization of HIV-1 Infected, Pregnant Women With CD4 Lymphocyte Counts >= 400/mm3: A Phase I Study of Safety and Immunogenicity of MN rgp120/HIV-1 Vaccine (NOTE: Some Patients Receive Placebo)
Condition: HIV Infections; Pregnancy
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety of rgp120/HIV-1MN vaccine in HIV-1 infected pregnant women with CD4
      counts >= 400 cells/mm3. To evaluate the immunogenicity of this vaccine in pregnant women and
      the passive acquisition of vaccine-specific antibody in their infants. To evaluate the
      induction or augmentation by rgp120/HIV-1MN vaccine of mucosal immune response in the
      gastrointestinal and reproductive tracts during pregnancy. To isolate and genetically
      characterize the HIV-1 present in cervicovaginal fluid specimens of pregnant women and
      compare it to that present in their peripheral blood mononuclear cells and to that of their
      infected infants.

      Evidence suggests that an advanced stage of disease with high plasma viremia is associated
      with increased transmission of HIV-1 to the fetus. Slowing the progression of disease,
      reducing the titer of virus in plasma, and increasing the titer of epitope-specific antibody
      are potentially attainable goals through active immunization of the mother during pregnancy.
    

Detailed description: 
      Evidence suggests that an advanced stage of disease with high plasma viremia is associated
      with increased transmission of HIV-1 to the fetus. Slowing the progression of disease,
      reducing the titer of virus in plasma, and increasing the titer of epitope-specific antibody
      are potentially attainable goals through active immunization of the mother during pregnancy.

      Pregnant women are randomized to receive an initial injection of MN rgp120 vaccine or alum
      placebo between week 16 and week 24 of gestation, followed by monthly booster injections
      concluding at the end of pregnancy, for a total of five injections. Patients may have
      optional booster immunizations (vaccine or placebo) at 3, 6, 9, and 12 months after delivery.
      Mothers and infants are followed through 18 months after delivery. Per 06/94 addendum,
      patients will be contacted once or twice per year for at least 5 years to check on health
      status of patient and child. PER 12/21/94 ADDENDUM, post-partum immunizations are
      discontinued.
    

Intervention name(s): rgp120/HIV-1MN
Intervention type(s): Biological
Intervention model: Parallel Assignment
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; Pregnancy; Pregnancy Complications, Infectious; HIV Envelope Protein gp120; AIDS Vaccines; HIV Therapeutic Vaccine
Allogenic Bone Marrow Transplantation (BMT) Compare With Cytoreduction and Chemotherapy in Acute Lymphoblastic Leukemia (ALL) Patients
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Patients with newly diagnosed Acute lymphoblastic leukemia after providing consent, will be
      screened for eligibility. Eligible patients will be treated with Vincristine (1 mg/m2 at Day
      1 and Day 8), Dexamethasone 24 mg/d day 1-15 and IT at Days 1, 4, 8 and 12. At day 14
      patients will be randomized in two group. BMT group who have donor and Chemotherapy group who
      don't have suitable donor. BMT group treated with allogenic Bone Marrow Transplantation and
      Chemotherapy treated with Cyclophosphamide at day 15, Daunorubicin at day 15-18, Vincristine
      at day 15 and 22 and Dexamethasone at day 12-28 followed by standard chemotherapy. In BMT
      group patients will be received CNS radiotherapy at +100 day after transplantation.
    


Intervention name(s): Bone Marrow Transplantation; Chemotherapy
Intervention type(s): Procedure; Procedure
Intervention description(s): Allogenic Bone Marrow Transplantation; Cyclophosphamide 1200 mg/m2 D15
Daunorubicin 45 mg/m2 D15-D18
Vincristine 1 mg/m2 D15, D22
Dexamethasone 24 mg/d D12-D28
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ALL; BMT; Chemotherapy; Allogenic
Changing Lifestyle in Children
Condition: Cardiovascular Risk
Study type: Interventional
Phase: Phase 4

Summary: 
      A lifestyle intervention aimed at improving exercise levels in primary school children.
    


Intervention name(s): Eating habits, diet and exercise
Intervention type(s): Behavioral
Intervention description(s): Programme of change to eating habits, diet and exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Beetroot Juice Supplementation in Basketball Players
Condition: Dietary Supplement; Sport Performance
Study type: Interventional

Summary: 
      Whereas beetroot juice (BJ) supplementation is shown to increase physical performance in
      endurance activities, its benefits in team sports has been barely studied. In this randomized
      placebo-controlled study, we investigated the effects of BJ acute supplementation in
      improving neuromuscular performance and physical match activity in basketball.
    

Detailed description: 
      Whereas beetroot juice (BJ) supplementation is shown to increase physical performance in
      endurance activities, its benefits in team sports has been barely studied. In this randomized
      placebo-controlled study, we investigated the effects of BJ acute supplementation in
      improving neuromuscular performance and physical match activity in basketball.Testing
      sessions will comprised a neuromuscular test battery consisting of a countermovement jump
      (CMJ), isometric handgrip strength, 10-m/20-m sprint and agility T-test, followed by a
      40-minute simulated basketball match. Physical match activity (distances, speeds,
      accelerations and decelerations) will be monitored in real time using an inertial tracking
      system
    

Intervention name(s): Beetroot juice (BJ) acute supplementation; Placebo acute supplementation
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): One serving 140 mL of BJ (12.8 mmol of NO3-; Beet-It-Pro Elite Shot, James White Drinks Ltd., Ipswich, UK) after an overnight fast and 3 h before initiating the testing session.; One serving placebo drink (0.08 mmol of NO3-; Salud Viva, Nano Salud 32 S.L) after an overnight fast and 3 h before initiating the testing session.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Sleep Quality During COVID-19 Containment in Children Whether or Not Usually Followed in Child Psychiatry
Condition: Sleep Disturbance
MeSH terms: COVID-19; Dyssomnias; Parasomnias
Study type: Observational

Summary: 
      The purpose of this study is to determine whether sleep disturbances in children aged 7 to 12
      during COVID-19 containment are more prevalent in children who received routine psychiatric
      care before containment compared to children who don't have any psychiatric care.
    

Detailed description: 
      The coronavirus epidemic reached France in January 2020 and the WHO declared the COVID-19
      outbreak was a pandemic on 11 March 2020. In response to this pandemic the French government
      announced national containment starting on 17 March 2020. Some recent studies suggest that a
      containment duration of more than 10 days and an extension beyond the originally announced
      duration would increase the psychological impact of it.

      Sleep is a vital function that contributes to the proper neurophysiological and psychological
      development of human beings especially children. Sleep disorders can have a major impact on a
      child's behavior, mood, cognitive performance and metabolism. Sleep disorders are often
      associated with depression, anxiety and cognitive changes. Chronic sleep disorders are also
      risk factors for mental illness To our knowledge, no study targeting the quality of sleep in
      children who usually receive psychiatric care is underway or has been published. It is
      essential to ask what the quality of sleep in children with a psychiatric diagnosis who
      suddenly lose their bearings and their usual daily routine (school, therapeutic groups, day
      hospitals, etc.) after several weeks of containment.

      This study is designed to assess different parameters in the 2 groups of children (healthy
      volunteers and Child with follow-up in child psychiatry) :

        -  the sleep quality,

        -  the depression level,

        -  the anxiety level,

        -  if socio-demographic factors have an influence on sleep disorders,

        -  if there is a correlation between children's sleep quality, and anxiety level / sleep
           quality in their parents.
    

Intervention name(s): Questionnaires
Intervention type(s): Behavioral
Intervention description(s): Child of both groups enrolled, and their parents, must complete online questionnaires
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Child aged 7 to 11 years and 11 months included on the first day of containment in France
        on 17 March 2020 and their parents
      
Keywords: Children; Sleep Disturbance scale for children; Containment; COVID-19; Anxiety; Psychological Distress; Sleep Wake Disorders; Child Psychiatry; Mental Health
Proof-Of-Concept Investigation With a Neurosteroid Analog (Ganaxolone) as a Smoking Cessation Candidate
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to evaluate whether the investigational drug ganaxolone
      can help smokers quit smoking. Ganaxolone is a drug that has been investigated (in other
      research studies) for the treatment of seizures and migraines. This drug is considered
      investigational in the US.
    

Detailed description: 
      The purpose of this proof-of-concept study is to evaluate whether expired air carbon monoxide
      (CO) will be reduced and smoking cessation success rates enhanced for smokers who receive the
      neurosteroid analog ganaxolone. The trial will be seeking preliminary indications of efficacy
      and tolerability in the smoking population and allow us to estimate effect sizes for future
      controlled trials.
    

Intervention name(s): Ganaxolone; Nicotine Patch
Intervention type(s): Drug; Drug
Intervention description(s): Pre-Quit Period:
Beginning at Session P1, subjects will receive ganaxolone at a dose of 400mg total daily (200mg bid) for the first three days, 800mg total daily (400mg bid) for the next three days and 1200mg total daily (600mg bid) for the remainder of the first four weeks.
Post-Quit Period:
Following the quit-day, subjects will receive ganaxolone at a dose of (1200mg total daily) for the next week. Down-titration of ganaxolone will begin at post-quit week two. Subjects will receive ganaxolone at a dose of 800mg total daily (400mg bid) to take for three days and 400mg total daily (200mg bid) to take for three.; Pre-Quit Period:
Beginning at Session P2, subjects will receive active 21mg/24h nicotine patches to apply daily for the next two weeks.
Post-Quit Period:
Following the quit-day, subjects will continue to apply active nicotine patches daily for the remainder of the study (21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week).
Other intervention name(s): nicoderm
Intervention MeSH terms: Nicotine; Ganaxolone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smoking Cessation; Quit Smoking; Ganaxolone; Nicotine Patch
PRP Gel in Wound Closure in Recurrent CS
Condition: Previous Incision; Scar; Previous Cesarean Section
MeSH terms: Surgical Wound
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      There is limited application of the use of PRP in obstetrics, therefore there is a need for
      assessment if it is efficacy in improving skin wound healing in cesarean section.
    

Detailed description: 
      This study aims to assess the efficacy of injection of platelet rich plasma into the wound of
      recurrent cesarean section for improving wound healing and enhancing the shape of the wound
      in women undergoing cesarean section.
    

Intervention name(s): platelet rich plasma gel; saline
Intervention type(s): Biological; Biological
Intervention description(s): Platelet rich plasma is prepared from fresh whole blood which is collected from a peripheral vein stored in acid citrare dextrose solution A (ACD-A)anticoagulant and processed to increase platelets by separating various components of blood; 64 controlled women with recurrent cesarean section and fullfit to all inclusion and exclusion craiteria will reseve saline injection at time of wound closure
Other intervention name(s): PRP; platelete rich plasma (PRP)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment