bioihbjkbjnl/mcl2 huggingface dataset:
Electrophysiology in Congenital Cataract After Lensectomy and Anterior
Condition: Congenital Cataract
MeSH terms: Cataract
Study type: Observational

Summary: 
      In this prospective study , a cohort of 91 eyes with congenital cataract and 25 eyes normal
      eyes from Wenzhou medical university was erolled.91 eyes with congenital cataract was after
      lensectomy and anterior vitrectomy as test group, 25 normal eyes as control group. The a- and
      b-wave and PhNR related parameters was evaluated.
    

Detailed description: 
      Secondary IOL implantation in aphika children and lensectomy and anterior vitrectomy and
      primary IOL implantation in children with congenital cataract were both performed by the same
      surgeon(Z.Y.E).

      electroretinography and photopic negative response are performed to each patient.The research
      was to evaluate the relationship between the best corrected visionn and the related
      parameters of a- and b-wave and PhNR .
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        congenital cataract age from 1.5 years to 15 years who underwent cataract surgery at least
        1 year
      
Keywords: ERG
Safety and Immunogenicity of H1N1 Vaccines in Children Aged 6 Months to Less Than 9 Years of Age
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to characterize the safety and immune response of the H1N1
      (swine) flu vaccines GSK2340274A and GSK2340273A in children 6 months to less than 9 years of
      age.

      This Protocol Posting has been updated following the Protocol amendment 1 & 2, September and
      October 2009. The sections impacted are study design, objectives and analysis methods.
    

Detailed description: 
      Collaborators: United States Department of Health and Human Services, Office of Biomedical
      Advanced Research and Development Authority
    

Intervention name(s): GSK2340274A; GSK2340273A
Intervention type(s): Biological; Biological
Intervention description(s): Two intramuscular injections; Two intramuscular injections
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: influenza infection; Influenza Vaccines; GSK Bio's influenza vaccine GSK2340273A; GSK Bio's influenza vaccine GSK2340274A
Prolonged Exposure and Oxytocin
Condition: PTSD
Study type: Interventional
Phase: Phase 2

Summary: 
      Posttraumatic stress disorder (PTSD) is a chronic, debilitating anxiety disorder that may
      develop after direct or indirect exposure to traumatic events. Prolonged Exposure (PE) is a
      cognitive-behavioral psychotherapy modality with a wealth of empirical support demonstrating
      its efficacy to treat PTSD in a variety of populations. The neuropeptide oxytocin is a
      promising new pharmacotherapeutic agent with prominent anxiolytic effects . Despite a strong
      biological and theoretical rationale for investigating the potential effectiveness of
      augmenting PE with intranasal oxytocin, no studies to date have done so. The current study
      aims to address this important gap in the literature by examining changes in PTSD symptoms
      following PE treatment combined with a) 40 IU of intranasal oxytocin or b) placebo.
    


Intervention name(s): Oxytocin; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): 40 IU oxytocin nasal spray, self-administered; Saline nasal spray, self-administered
Other intervention name(s): Pitocin
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: posttraumatic stress disorder; oxytocin; Prolonged Exposure
Topical Challenge With Omiganan and Imiquimod in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study has a randomized, evaluator-blinded, vehicle- controlled study to assess the
      pharmacodynamics of omiganan and omiganan with imiquimod in healthy volunteers.
    


Intervention name(s): Omiganan; Imiquimod; Omiganan 1% and Imiquimod; Omiganan 2.5% and Imiquimod; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Omignan 1%, 2.5%; Imiquimod 15mg; Omiganan 1% and Imiquimod; Omiganan 2.5% and Imiquimod; Vehicle
Intervention MeSH terms: Antimicrobial Cationic Peptides; Imiquimod
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Effects of L-Citrulline or Citrulline-malate on Neuromuscular Performance in Resistance-trained Adults
Condition: Neuromuscular Performance
Study type: Interventional

Summary: 
      The main aim of this study is to compare the effects of L-Citrulline vs. Citrulline-malate on
      neuromuscular performance (maximal dynamic strength and maximal endurance strength) in
      resistance-trained adults.
    

Detailed description: 
      Nitric oxide (NO) is a ubiquitous gaseous molecule that plays a critical role in the
      regulation of cardiovascular function and in the signaling of multiple cellular processes.
      Specifically, NO could reduce the oxygen cost of exercise and adenosine triphosphate (ATP) in
      the production of muscle contractile force, improving calcium handling, glucose uptake and
      mitochondrial efficiency in muscle fibers. Therefore, it has been suggested that increasing
      the availability of NO through the oral intake of food and nutritional supplements may be
      useful to delay the onset of fatigue and improve performance in high-intensity efforts.

      L-citrulline is a nonessential amino acid involved in the urea cycle that acts as an
      endogenous precursor of L-arginine, being a more efficient alternative to L-arginine to
      increase the plasma concentration of L-arginine through the nitric oxide synthase (NOS)
      pathway.

      On the other hand, citrulline malate is an organic salt of L-citrulline and malate which has
      been shown to exert a small but significant ergogenic effect in different high-intensity
      efforts compared to a placebo. However, no study to date has compared L-citrulline VS.
      citrulline malate to assess whether there is an additive effect from malate to exercise
      performance.

      50 resistance-trained adults (50% women) will be randomized into three conditions
      (L-citrulline, citrulline-malate and placebo conditions) with 48 hours of separation between
      conditions. 48h previous to the randomization the participants will perform a familiarization
      to avoid the learning effects.

      Each evaluation day will conform to the following tests:

        -  Maximal dynamic strength of lower- and upper-body

        -  Maximal endurance strength of lower- and upper-body
    

Intervention name(s): L-citrulline; Citrulline-malate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 5 g of L-citruline + 5 g of additives; 8g of citrulline-malate + 2 g of additives; 10g of maltodextrine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: nitric oxide; dietary supplement; resistance training; citrulline malate
The ConnectedCancerCare Pilot Study (CCC)
Condition: Early-stage Breast Cancer; Breast Cancer Female; Survivorship; Cancer Survivors; Transitional Care
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This study is an NCI-funded, randomized control pilot trial to evaluate: (1) the feasibility
      and acceptability of a web-based, personalized navigation tool (ConnectedCancerCare) and (2)
      explore whether the tool improves delivery of team-based survivorship care for women who have
      recently finished primary breast cancer treatment.
    

Detailed description: 
      This study is a randomized control pilot trial involving 60 women newly diagnosed with
      early-stage breast cancer who are finishing primary treatment. Participants will be
      randomized either to the intervention arm (CCC website that provides information on
      team-based follow-up care for both cancer surveillance and preventive care) or the control
      arm (static online survivorship care plan template, adapted from the ASCO breast cancer
      survivorship template). The feasibility and acceptability of the tool and correlations with
      patient-reported outcomes will be assessed 3 months following the completion of a baseline
      survey via an online follow-up survey.
    

Intervention name(s): CCC website; Static care plan
Intervention type(s): Behavioral; Behavioral
Intervention description(s): ConnectedCancerCare (CCC) is a web-based guide to support survivorship care for women who have been treated for early-stage (stages 0-II) breast cancer. It encourages patients to utilize team-based care by oncologists and primary care physicians and provides them with the information on cancer surveillance, screenings and preventive healthcare during survivorship.; The control is a static survivorship care plan template in PDF format that includes information similar to what an oncologist currently provides as "standard of care."
Other intervention name(s): ConnectedCancerCare
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized control pilot trial of a web-based, personalized navigation tool to support the continuing and team-based care of early-stage breast cancer patients who have completed their primary cancer treatment. Patients will be randomized to either the intervention (n=30), a personalized website that guides team-based, survivorship care or to the control (n=30), an static online survivorship care plan.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Breast cancer; Survivors; Survivorship plan; Transitional cancer care
A Study to Evaluate the Safety and Efficacy of Therapeutic Hepatitis B Vaccine
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A single center, open labeled phase I/IIa study to evaluate safety, tolerability and efficacy
      of a therapeutic hepatitis B vaccine in oral antiviral drug-treated chronic hepatitis B virus
      carriers
    

Detailed description: 
      -  Objectives: To explore the appropriate dose of a therapeutic hepatitis B vaccine through
           the evaluation of safety, tolerability, and efficacy

        -  Subjects: Chronic hepatitis B carrier with normal ALT range

        -  Study hypothesis: The immune tolerance break and strong immune responses in the chronic
           hepatitis B carrier could be achieved with therapeutic hepatitis B vaccine containing
           novel adjuvant
    

Intervention name(s): CVI-HBV-002
Intervention type(s): Biological
Intervention description(s): Investigational product: CVI-HBV-002
Dose: 20ug or 40ug
Frequency: 3 or 6 times
Vaccination schedule: 0, 1, 2 months or 0, 1, 2, 3, 4, 5 months
Administration route: Intramuscular injection
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Preoperative Vitamin D Levels and Respiratory Complications of General Anesthesia
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      Vitamin D deficiency is a commonly observed health problem in the world. With a role in many
      chronic diseases and especially lung diseases, the importance of vitamin D deficiency in
      anesthesia management is increased. This research aims to investigate whether there is a
      correlation between the respiratory complications occurring in patients under general
      anesthesia and preoperative vitamin D levels.
    

Detailed description: 
      This study included 95 adult cases aged from 18-65 years operated under general anesthesia.
      The cases had total 25-hydroxyvitamin D (25OHD) levels identified in blood samples before the
      operation. Patients given routine general anesthesia and postoperative monitoring procedures
      were assessed in terms of respiratory complications during anesthesia induction, extubation,
      anesthesia recovery and the first 24 hours postoperative.

      This research observed that patients with low preoperative 25OHD vitamin levels encountered
      respiratory complications related to general anesthesia more often. Especially in the early
      postoperative period there is a very significant difference between complications and low
      25OHD vitamin levels. Our study results show that low vitamin D levels may be a potential
      risk in terms of respiratory complications related to general anesthesia causing severe
      morbidity and mortality increase. The results lead to the consideration that optimizing
      vitamin D levels in the preoperative period for patients undergoing general anesthesia may
      aid in reducing complications.
    

Intervention name(s): Vitamin D
Intervention type(s): Other
Intervention description(s): Vitamin D, general anesthesia, respiratory complications
Other intervention name(s): Anesthesia, respiratory complications
Intervention MeSH terms: Vitamin D
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Vitamin D; general anesthesia; respiratory complications
Evaluation of Use of Brain Activity Monitoring for Evaluation of Depression Treatment
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This study evaluates the use of brain activity monitoring for early identification of
      pharmaceutical treatment efficacy and development of depression deterioration events.
    

Detailed description: 
      The study will be conducted in two arms:

      In arm I, participants diagnosed with depression. In arm II, healthy participants.

      Arm I - Participants that need to start or switch their pharmacological antidepressant
      therapy will be recruited. Their clinical status will be evaluated and their EEG
      characteristics will be collected.

      Arm II - Clinical and EEG characteristics of Healthy volunteers will collected on a similar
      timetable.
    

Intervention name(s): EEG monitoring
Intervention type(s): Device
Intervention description(s): EEG evaluation will be done using two off the shelf EEG devices for research and consumer use. The first one is a device called MindWave by NeuroSky ltd (http://neurosky.com) the second called EPOC by Emotiv ltd (https://emotiv.com/epoc.php).
EEG evaluation will be conducted for a total duration of 20 minutes with and without auditory stimulation. The auditory stimulation will be performed using standard headphone or earphones to reduce external noises.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Bleeding in Critically Ill Children With Underlying Oncologic Diagnoses
Condition: Cancer; Bleeding
MeSH terms: Hemorrhage; Critical Illness
Study type: Observational

Summary: 
      "Bleeding in Critically Ill Children with Underlying Oncologic Diagnoses ," will be a
      prospective observational cohort study looking at the epidemiology of bleeding in the
      pediatric ICU population at MSK.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All subjects admitted to the pediatric ICU at MSKCC will be included in this observational
        study.
      
Keywords: Critically Ill Children; 19-407
Replacement of Saturated Fat in Dairy on Total Cholesterol
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      The consumption of milk and dairy products is recognised as an essential part of a healthy
      diet as it represents an important source of key micro- and macronutrients. Nevertheless,
      there is still a widespread conviction that the overall high energy density and concentration
      of long-chain saturated fatty acids (SFA) present in dairy have detrimental health effects,
      contributing to the progression of cardiovascular disease, obesity and diabetes.

      Supplementation of the bovine diet with a source of MUFA, such as rapesee oil, has become an
      achievable strategy in order to reduce the amount of SFA present in dairy products.

      The aim of this project is to observe the effects of three types of dairy products (UHT milk,
      cheese and butter) produced from milk derived from cows fed withhigh-oleic sunflower oil, on
      CVD risk biomarkers and plasma total cholesterol levels in adults with an increased risk of
      developing CVD. The aim is to determine whether an isoenergetic exchange of dairy products
      will affect vascular function and CVD biomarkers.
    


Intervention name(s): MUFA-rich dairy products (UHT milk, cheese and butter); Conventional dairy products (UHT milk, cheese, butter)
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Milk fatty acids; Total cholesterol; Vascular function; Blood pressure
A Phase 1 Bioequivalence Study of Efgartigimod PH20 SC Administered Via a Prefilled Syringe Versus a Vial+Syringe Presentation in Healthy Adults
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open-label, parallel-group, single-dose study comparing the
      pharmacokinetics of efgartigimod in blood following a single administration of efgartigimod
      PH20 SC via a prefilled syringe versus a vial + syringe in healthy participants.
    


Intervention name(s): efgartigimod PH20 SC as a prefilled syringe presentation; efgartigimod PH20 SC as a vial + syringe presentation
Intervention type(s): Biological; Biological
Intervention description(s): efgartigimod PH20 SC as a prefilled syringe presentation; efgartigimod PH20 SC as a vial + syringe presentation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Efficacy of GXR as Adjunctive Therapy With Psycho-stimulant on Executive Function in Children With ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      This study looks to examine whether or not INTUNIV extended release can help children aged
      6-12 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) in improving
      Executive Function when added to their usual care stimulant therapy. Executive functions are
      a set of mental processes that include emotional control, planning, organization, working
      memory, inhibition of behaviors, and managing time and space. As children with ADHD usually
      have difficulties with Executive Function, and Executive function difficulties lead to more
      difficulties in school and behaviour, it is anticipated that adding INTUNIV extended release
      to usual stimulant therapy will improve Executive Function scores as rated by parents and
      teachers. Improvements in quality of life will also be measured.
    

Detailed description: 
      Although stimulant medications have been shown to have positive impact on executive function
      (EF) (Findling et al, 2009; Hale et al. 2011), little has been documented about the effect of
      INTUNIV extended release on EF in children. The manifestation of clinical symptoms related to
      impairment in EF often leads to the search for additional treatment options and in many cases
      to adjunct therapies to the traditional stimulant medication treatment regimen. Demonstrating
      that the addition of INTUNIV extended release to usual stimulant therapy is effective for
      symptom control as well as in improving EF may influence clinical treatment algorithms and
      the need for health care resources to effectively manage patients. Since EF deficits
      negatively impact academic achievement and behavior at school and because children spend a
      large number of daytime hours at school, the concordance of any reported improvement in the
      school and the home environment will be examined. Overall improvement in quality of life with
      the addition of INTUNIV extended release will also be evaluated.
    

Intervention name(s): Guanfacine extended release; Placebo; Stimulant therapy
Intervention type(s): Drug; Drug; Drug
Intervention description(s): patient will continue to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine)
Other intervention name(s): Intuniv extended release
Intervention MeSH terms: Guanfacine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactivity Disorder; Intuniv extended release; Executive Function; Quality of Life
A Study to Evaluate Safety and Efficacy Following Dosing of Oxycodone/Naltrexone for Treatment of Adults With Pain Following Bunionectomy Surgery
Condition: Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 3
      study to evaluate the efficacy and safety of the administration of multiple doses of
      Oxycodone Hydrochloride plus Naltrexone Hydrochloride (a) or Oxycodone Hydrochloride plus
      Naltrexone Hydrochloride (b) in patients who have undergone primary, unilateral, distal first
      metatarsal bunionectomy with osteotomy and internal fixation.
    

Detailed description: 
      The study is designed to evaluate the safety and efficacy of oxycodone/naltrexone (a) and
      oxycodone/naltrexone (b) versus placebo. During the blinded phase of the study (inpatient
      portion) the dosing regimen is 1 capsule containing Oxycodone Hydrochloride plus Naltrexone
      Hydrochloride (a) or Oxycodone plus Naltrexone Hydrochloride (b) or placebo taken with 4 to 6
      ounces (oz) of water every 6 hours (q6h) for 48 hours following the first dose (Multiple-dose
      Period) while in-house. Then for the open-label phase of the study (outpatient portion)
      dosing will occur every 4 to 6 hours prn with Oxycodone plus naltrexone. The active and
      placebo study medications will appear identical. Study subjects with acute postoperative pain
      of moderate to severe intensity following unilateral bunionectomy surgery will be randomized
      after surgery, and will stay at the study center for the duration of the 48-hour double-blind
      period after dose 1 of study medication. The study will be conducted in the following 4
      periods: 1) a pre-treatment period, 2) a multiple-dose inpatient period (double-blind), 3) a
      multiple-dose outpatient period (open-label), and 4) End of Study/Follow-up.
    

Intervention name(s): Oxycodone Naltrexone (a); Oxycodone Naltrexone (b); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Matches both experimental drugs
Intervention MeSH terms: Naltrexone; Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment