bioihbjkbjnl/mcl2 huggingface dataset:
Dopamine Versus Norepinephrine Under General Anesthesia
Condition: Anesthesia; Infant; Congenital Heart Disease; Hemodynamic Instability
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional
Phase: Phase 3

Summary: 
      Participants under general anesthesia will be randomly treated with an adjusted dose dopamine
      or norepinephrine to elevate 10% of mean arterial pressure. Systemic hemodynamic data is
      recorded by PRAM and the change of cardiac index is compared between groups.
    

Detailed description: 
      After intubation under general anesthesia, radial arterial is cannulated and pressure
      transducer is connected to MostCare(core technique PRAM). CI, SVRI, SVI, SVV, dp/dt and HR
      are recorded before and after a infusion of dopamine or norepinephrine to elevate 10% of mean
      arterial pressure. Changes of these hemodynamic data are compared.
    

Intervention name(s): norepinephrine; dopamine
Intervention type(s): Drug; Drug
Intervention description(s): to treat hypotension under general anesthesia with norepinephrine; to treat hypotension under general anesthesia with dopamine
Intervention MeSH terms: Dopamine; Norepinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: norepinephrine; dopamine
Systems of Underprivileged Preschoolers in Their Home and Preschool EnviRonment: Family Intervention Trial
Condition: Child Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      This study will evaluate the effectiveness of SuperFIT, an integrative lifestyle intervention
      for preschool children. It will consist of both an preschool component and a family component
      and is aimed at increasing healthy nutrition and physical activity. Half of the participating
      preschools will implement SuperFIT, while the other half of the preschools will continue as
      usual.
    


Intervention name(s): SuperFIT
Intervention type(s): Behavioral
Intervention description(s): Behavioural intervention with two components. One component will consist of social and physical environmental changes at the preschools and the other component consists of a family educational program.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Transversus Abdominis Plane Block in Children Undergoing Open Pyeloplasty Surgery
Condition: Anesthesia
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectiveness of transversus abdominis plane
      (TAP) block in reducing postoperative opioid requirements and pain after open pyeloplasty
      surgery in children.
    

Detailed description: 
      Primary open pyeloplasty is a common elective surgical procedure at The Hospital for Sick
      Children. All children are given fentanyl plus local anesthetic wound infiltration for
      intraoperative analgesia. A retrospective audit demonstrated that 63% of children required
      additional opioid treatment in the early recovery period following surgery. Concern exists
      regarding potential side effects of opioids including nausea or vomiting, respiratory
      depression, pruritus, over-sedation and delayed transition to oral intake. More importantly,
      children may under-report their pain or pain may not be recognized by medical staff leading
      to inadequate provision of analgesia. This suggests that the use of a regional technique,
      such as a TAP block, may benefit children undergoing open pyeloplasty.

      The ultrasound guided TAP block introduces a local anaesthetic to the transversus abdominis
      plane which is one of three muscle layers in the abdominal wall. This results in a block of
      the nerves leading to the abdominal wall thereby reducing pain sensations.
    

Intervention name(s): Transversus Abdominis Plane Block; Standard Anesthesia
Intervention type(s): Procedure; Procedure
Intervention description(s): A block needle will be advanced in a medial to lateral direction until the tip is visualized in the transversus abdominis plane. After negative aspiration 0.4 ml/kg of bupivacaine 0.25% with 1:200 000 epinephrine will be injected. The total dose of bupivacaine will not exceed 2 mg/kg and the total volume will not be more than 20 ml.; Local field infiltration with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg before skin incision.
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pediatrics; anesthesia; pyeloplasty; Transversus Abdominis Plane Block; Regional Anesthesia
Human Irisin Concentration in Sarcopenia
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Observational

Summary: 
      Irisin has been identified as a novel myokine that drives brown-fat-like conversion of white
      adipose tissue. In this cross-sectional study, the researches investigated whether serum
      irisin levels are decreased in patients with sarcopenia compared with control subjects with
      normal muscle mass, and assessed the association between serum irisin levels and various
      metabolic parameters.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients in Korean Sarcopenic Obesity Study (KSOS), an prospective observational cohort
        study designed to examine the prevalence of sarcopenia and sarcopenic obesity in Korean
        adults and to evaluate their effects on metabolic disorders and health outcomes.
Efficacy and Safety of Biphasic Insulin Aspart 30 With Metformin in Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is conducted in Africa. The aim of this trial is to evaluate the efficacy and
      safety of biphasic insulin aspart plus OAD compared to biphasic insulin aspart alone on blood
      glucose control in type 2 diabetes.
    


Intervention name(s): biphasic insulin aspart; metformin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Metformin; Insulin Aspart; Biphasic Insulins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Adjuvant Treatment With a Glycine Uptake Inhibitor in Participants With Negative Symptoms of Schizophrenia (P05695) (MK-8435-001)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether MK-8435 (Org 25935) is more effective than
      placebo in improving negative symptoms in participants with schizophrenia who are
      concurrently treated with a stable dose of a second generation antipsychotic.
    

Detailed description: 
      The primary features of schizophrenia are characterized by positive (irrational thoughts
      and/or behavior) and negative symptoms. Negative symptoms are the gross absence of normal
      behavior and emotions, and usually include a general lack of engagement, social withdrawal,
      and loss of goal-directed behavior.

      Negative symptoms may strongly affect daytime activities and quality of life. The effects of
      currently available antipsychotics on negative symptoms are not satisfactory and leave much
      room for improvement. MK-8435 (Org 25935) is an investigational drug that may help to correct
      the above characteristics of schizophrenia by facilitating the messenger function of an amino
      acid in the brain, called glutamate. Preliminary data suggest that lowered glutamate levels
      in schizophrenia are associated with a failure to activate relevant areas in the forebrain
      and with prominent negative symptoms.
    

Intervention name(s): MK-8435 (Org 25935) 4-8 mg; Placebo; MK-8435 (Org 25935) 12-16 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally 2 times a day (BID) for a final concentration of 8-16 mg/day; Matching placebo for MK-8435 (Org 25935) administered orally BID; Administered orally BID for a final concentration of 24-32 mg/day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Negative symptoms; Glycine Uptake inhibitor; Add-on treatment; Second Generation Antipsychotic
Frozen-thawed Embryo Transfer (FTET) Cycle Follow-up Protocol (P06031)
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this follow-up study is to collect the outcome and safety of FTET cycles after
      the embryos are cryopreserved in P06029 (NCT01144416). P06029 was a study in which a single
      injection of corifollitropin alfa (SCH 900962) was compared with daily recombinant follicle
      stimulating hormone (recFSH) injections in women aged 35 to 42 years undergoing controlled
      ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm
      injection (ICSI).
    


Intervention name(s): Corifollitropin alfa; recFSH (follitropin beta)
Intervention type(s): Biological; Biological
Intervention description(s): Single injection of 150 μg corifollitropin alfa administered under protocol P06029; Daily recFSH 300 IU administered under protocol P06029.
Other intervention name(s): Follistim® AQ Cartridge
Intervention MeSH terms: Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Reproductive Techniques, Assisted; Follicle Stimulating Hormone, Human; Fertilization In Vitro
Observational Study to Observe the Safety of Levemir® Treatment in Children and Adolescents With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      This observational study is conducted in Europe. The trial aims to observe the incidence of
      serious adverse drug reactions in children and adolescents with type 1 diabetes during
      Levemir® treatment.
    


Intervention name(s): insulin detemir
Intervention type(s): Drug
Intervention description(s): No extra intervention, only normal clinical practise for treatment of type 1 diabetes
Other intervention name(s): Levemir®
Intervention MeSH terms: Insulin Detemir
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children Age 6 - 18 with type 1 diabetes
Alterations in Gait, Strength, and Power After Ruck Marching
Condition: Exercise; Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The purpose of this study is to determine change in injury risk and performance variables in
      males and females after walking unloaded and carrying a load with two different distributions
      (high-pack placement and mid-pack placement) to identify differences in injury risk
    


Intervention name(s): Loaded Walking High; Loaded Walking Mid; Walking
Intervention type(s): Other; Other; Other
Intervention description(s): Walking three miles on a treadmill at a self-selected speed while wearing a backpack with weight carried high on the back; Walking three miles on a treadmill at a self-selected speed while wearing a backpack with weight carried on the mid-back; Walking three miles on a treadmill at a self-selected speed
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Tailored Computerized Mobilization of the Cervical Spine Utilizing the Occiflex Device for the Treatment of Chronic Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is intended to examine the safety and efficacy of computerized mobilization of the
      neck for the treatment of patients with chronic neck pain. This is a third continuation study
      aimed at examining the Occiflex Robotic System. This time we will be studying tailored or
      personalized three dimensional movement of the neck.
    


Intervention name(s): Occiflex Robotic Intervention System
Intervention type(s): Device
Intervention description(s): Occiflex is a robotic system which is comprised of a cradle moved in a three dimension space with six degrees of freedom. It allows the therapist to tailor a personalized course of 3-D mobilization of the head and neck.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Neck Pain, Occiflex, Computerized Mobilization
A Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Celiac Disease
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the efficacy and safety of AMG 714 for the attenuation of
      the effects of gluten exposure in adult patients with celiac disease during a gluten
      challenge.
    


Intervention name(s): AMG 714; Placebo; Placebo Gluten Challenge; Gluten Challenge
Intervention type(s): Biological; Biological; Other; Other
Intervention description(s): AMG 714 administered by subcutaneous injection; Matching placebo to AMG 714 administered by subcutaneous injection; Gluten-free cookies (Finnish rusks); Gluten-containing cookies (Finnish rusks), 1-2 g gluten per serving
Other intervention name(s): PRV-015
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: celiac; gluten; Interleukin 15 (IL-15); AMG 714; gluten challenge
Comparative Effects of Milk Thistle Extract With Vitamin-E in Hemodialysis Patients
Condition: Hemodialysis; End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      For end-stage renal disease (ESRD) patients, cardiovascular disease remains the single most
      common cause of excess morbidity and mortality. Among the examined nontraditional risk
      factors, an increase in oxidative stress as well as inflammation are postulated to contribute
      to excessive cardiovascular risk in this population.

      Flavonoids are naturally occurring substances that possess various pharmacological actions
      and therapeutic applications. Some due to their phenolic structures have antioxidant effect
      and inhibit free radical-mediated processes, as well as anti-inflammatory effects.
      Silymarin,a mixture of three isomeric flavonolignans, is isolated from milk thistle (Silybum
      marianum) seeds, and is proven to have anti-oxidant, anti-inflammatory, cell regenerating,
      and antifibrotic action.

      In this study, the effect of silymarin on oxidative stress and inflammation (2 major risk
      factors for cardiovascular morbidity and mortality in hemodialysis patients)is evaluated, and
      compared to vit E, a well known antioxidant.
    


Intervention name(s): Milk Thistle extract; vit E; vit E + Milk Thistle extract
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 tablet equivalent to 140 mg of silymarin, 3 times daily for 3 weeks; 200 mg twice daily for 3 weeks; 200 mg vit E twice daily + 1 tablet of Milk Thistle 3 times daily for 3 weeks
Intervention MeSH terms: Vitamin E; alpha-Tocopherol; Tocopherols
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: hemodialysis; oxidative stress; plasma malondialdehyde; Glutathion peroxidase
Adolescent SCreening To Help Eliminate Misuse
Condition: Substance Use
MeSH terms: Substance-Related Disorders
Study type: Observational

Summary: 
      The specific aim of this study is to evaluate the performance of three substance use
      screening instruments (S2BI, BSTAD, and TAPS Tool) against a criterion standard of Diagnostic
      Statistical Manual - 5 (DSM-5) substance use disorder (SUD) diagnoses in an adolescent
      population.
    

Detailed description: 
      This study seeks to evaluate the psychometric properties of three substance use screening and
      brief assessment tools for adolescents against criterion standard of Diagnostic and
      Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) substance use disorder
      diagnoses in a population of adolescents who receives care at a participating primary care
      practice; or, for an initial evaluation at a substance use disorders program for youth. The
      three tools to be tested are the Brief Screener for Tobacco, Alcohol and Drugs (BSTAD);
      Screening to Brief Intervention (S2BI) screening tool; and the Tobacco, Alcohol, Prescription
      medications, and other Substance (TAPS) Tool. BSTAD and S2BI were developed specifically for
      use with adolescents and each has been validated in a single trial. These tools use past-year
      "frequency of use" questions to determine risk level for a substance use disorder. The TAPS
      tool includes both screening and brief assessments and while it has been studied more
      extensively in adult primary care patients, its validity with adolescents is not known. For
      youth, alcohol, marijuana and tobacco use, and particularly early initiation, are associated
      with greater risk of substance use disorders, use of illicit drugs, misuse of opioids, and
      opioid use disorders. Thus, identifying and addressing substance use early is an important
      form of prevention that can be delivered in medical care settings for this age group.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Recruitment and study procedures may occur either in-person or remotely. We will recruit
        participants to enroll in the study from participating health care sites. These will
        include 1) an outpatient adolescent substance use disorders program at a pediatric hospital
        (ASAP, Boston Children's Hospital), 2) the adolescent medicine program at a federally
        qualified health center (FQHC) in Boston (Martha Elliot Health Center (MEHC), Boston
        Children's Hospital), and 3) community-based primary care pediatrics practices that
        participate in the Pediatric Physicians' Organization at Children's (PPOC). The FQHC is
        considered a primary care sites participating in this study.
      
Keywords: Screening; Adolecents; SBIRT; Substance Use
Symptoms and Function During and After Pregnancy
Condition: Pelvic Girdle Pain
MeSH terms: Pelvic Girdle Pain
Study type: Observational

Summary: 
      The purpose of this study is to:

        1. describe degree of symptoms and disability during and after pregnancy

        2. to examine if women with pelvic girdle pain are able to correctly mark their pain
           location on a pain drawing

        3. to examine the responsiveness of The Pelvic Girdle Questionnaire
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        pregnant women in week 32 - 36
Luminopia One Amblyopia Vision Improvement Study
Condition: Amblyopia
MeSH terms: Amblyopia
Study type: Interventional

Summary: 
      The objective of the study is to demonstrate the safety and efficacy of Luminopia One in
      amblyopia patients with amblyopia associated with anisometropia and/or with mild strabismus.
    

Detailed description: 
      The proposed study is a multi-center randomized controlled clinical trial which compares the
      mean change in amblyopic eye Best Corrected Visual Acuity from baseline with Luminopia One
      ("therapeutic") to refractive correction ("control"). One-hundred and forty participants (n =
      140) aged 4-7 years will be enrolled. Participants will be randomized 1:1 to the "therapeutic
      group ", to use Luminopia One, or the "control group", to undergo continued refractive
      correction, for 12 weeks of treatment.
    

Intervention name(s): Luminopia One; Refractive Correction
Intervention type(s): Device; Device
Intervention description(s): Luminopia One is a virtual-reality based digital therapeutic that applies therapeutic modifications in real-time to cinematic content to rebalance visual input and treat amblyopia.; Standard of care refractive correction (ex. spectacles)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Fermentation Rate of Infant Formula
Condition: Healthy
Study type: Observational

Summary: 
      It is hypothesized that there will be no difference in the breath hydrogen excretion between
      the 2 different prebiotic formulas.
    

Detailed description: 
      This pilot study is looking at how a formula with one of two different prebiotic blends may
      alter the hydrogen level in an infant's exhalations in the hours after feeding. Higher levels
      for a longer period may signal higher levels of short chain fatty acids and bifidobacteria,
      both beneficial for gastrointestinal health. The higher levels may be the result of the
      formula undergoing a slower digestion, producing more fermentation.

      The study will compare a formula, similar to one currently on the market, with added
      prebiotics using a special breathing mask designed to be held to the infant's mouth and nose
      long enough to capture the infant's exhaled breath which will then be tested for Hydrogen
      content.
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy infants.
      
Keywords: health benefits of infant formula